PeritX 50-9050ARecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10885403500831), received between Jun 29, 2022 and Jul 10, 2026 — classified as 3 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (21 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25787644 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE VALVE WAS LEAKING DURING USE. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE, AFTER WHICH SUCCESSFUL DRAINAGE WAS ACHIEVED. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION REQUIRED, AND NO IMPACT ON THE PATIENT OR COURSE OF TREATMENT. THE SAFETY VALVE WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS PERFORMED BY AN EWIMED EMPLOYEE AT THE PATIENT¿S HOME, WITH THE CATHETER PLACED IN THE ASCITES POSITION SINCE (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412809 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN UNKNOWN SUBSTANCE WAS OBSERVED PROTRUDING FROM THE SITE OF THE PERITX ABDOMINAL DRAIN DEVICE. DURING FOLLOW UP IT WAS REPORTED THAT THE TREATING PHYSICIAN ELECTED TO MANAGE THE ISSUE WITH ORAL ANTIBIOTICS. THE CLINICIAN DECIDED TO LEAVE THE DRAIN IN SITU, AS THE PATIENT IS CURRENTLY RECEIVING END OF LIFE CARE AND THE PHYSICIAN DID NOT WANT TO SUBJECT THE PATIENT TO A REMOVAL AND REINSERTION PROCEDURE. THE DRAIN REMAINS IN SITU, AND THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 24631922 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT THE VALVE OF THE PERITX PERITONEAL CATHETER WAS BROKEN OR DAMAGED, RESULTING IN LEAKAGE. NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO EXPOSURE TO BLOOD OR BODILY FLUIDS. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE. DESPITE THE LEAKAGE, DRAINAGE REMAINED SUCCESSFUL, WITH NO IMPACT ON THE PATIENT AND NO CHANGES TO THE COURSE OF TREATMENT. THE CATHETER, POSITIONED IN THE PLEURA, HAD BEEN IN PLACE SINCE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24372398 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2025, A PATIENT CAME TO THE UGEI WITH INFLAMED SKIN ON THE PATHWAY LOOKING LIKE INFECTIOUS DERMOHYPODERMATITIS AND THE INTERVENTIONAL RADIOLOGY UNIT WAS CONCERNED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24084421 ↗
• MalfunctionJan 5, 2026Device Handling Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PERITX PERITONEAL CATHETER MINI KIT VALVE WAS DAMAGED BY THE PATIENT. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. SUCCESSFUL DRAINAGE WAS ACHIEVED. NO MEDICAL INTERVENTION WAS REPORTED. NO EXPOSURE TO BLOOD / BODILY FLUID WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23970717 ↗
• MalfunctionDec 12, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED ON NOVEMBER 20, 2025, THAT DURING PERITX DRAIN PLACEMENT, THE CONDUCTOR BECAME STUCK INSIDE THE PEEL-AWAY CATHETER AND COULD NOT BE REMOVED AFTER MULTIPLE ATTEMPTS. THE PEEL-AWAY AND DILATOR WERE REMOVED, BUT THE CONDUCTOR REMAINED LODGED UNTIL FREED USING AN ADDITIONAL 4F CATHETER. THE CONDUCTOR WAS FOUND SPIRAL-SHAPED WITH SURFACE COATING ROLLED UP. A NEW PERITX SET WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXPOSURE TO BLOOD/BODILY FLUIDS OCCURRED. DRAINAGE WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791149 ↗
• MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) , 2025, THE VALVE WAS REMOVED AS IT DETACHED (DOES NOT HOLD, SLIPPED OUT) AND SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS REPLACED, AND SUCCESSFUL DRAINAGE WAS ACHIEVED. NO MEDICAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23660382 ↗
• MalfunctionOct 29, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING USE OF THE PERITX PERITONEAL CATHETER MINI KIT, THE VALVE WAS DAMAGED BY OTHER UNKNOWN MATERIAL, AND THE SAFETY VALVE WAS FOUND BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE AND DRAINAGE WAS SUCCESSFUL. THERE WERE NO MEDICAL INTERVENTION AND THERE WAS NO EXPOSURE TO BLOOD/BODILY FLUID. NO IMPACT TO THE PATIENT WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT AN UNKNOWN MATERIAL WAS CONNECTED BY FORCE, BUT IT IS UNCLEAR WHAT MATERIAL COMPONENTS WERE CONNECTED BY FORCE. IT WAS CLARIFIED THAT THE VALVE WAS CRACKED BUT IT IS UNKNOWN IF THE VALVE DISCONNECTED. THE PATIENT IS BEING TREATED FOR ASCITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420412 ↗
• MalfunctionOct 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ON (B)(6) 2025 DURING USE OF THE PERITX PERITONEAL CATHETER MINI KIT A HOLE IN THE TUBE BEHIND THE VALVE WAS IDENTIFIED CAUSING LEAKAGE. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE AND DRAINAGE WAS SUCCESSFUL. THE PATIENT WAS NOT EXPOSURE TO BLOOD/BODILY FLUID AND THERE WAS NO MEDICAL INTERVENTION. NO PATIENT INJURY WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE TUBE WAS SHORTENED, AND A NEW VALVE WAS FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373338 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT THE VALVE OF THE PERITX PERITONEAL CATHETER KIT WAS DAMAGED. NO MEDICAL INTERVENTION WAS REQUIRED, AND THERE WAS NO EXPOSURE TO BLOOD OR BODY FLUIDS. THERE WAS NO REPORTED PATIENT INJURY. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23159356 ↗
• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT VALVE BROKEN/ DAMAGED/ DISCONNECTED RESULTING IN LEAKAGE. IT WAS FURTHER REPORTED THAT THE VALVE WAS REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22800710 ↗
• MalfunctionJul 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS NO CATHETER STICKER ON THE EVO. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385365 ↗
• MalfunctionJul 1, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE CATHETER WAS BLOCKED, AND AN ATTEMPT WAS MADE TO RESTORE PATENCY BY MILKING IT. IT WAS FURTHER REPORTED THAT THE VALVE WAS REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378653 ↗
• MalfunctionJan 23, 2025Break; Break

  INPUT TYPE: ORAL. INJURY (PATIENT / OTHER): NO. PRODUCT POSSIBLE INVOLVED IN INJURY: NO. PRODUCT AVAILABLE FOR INQUIRY: NO. LOCATION: 2 - WHEN USING. ORIGIN: PATIENT. COMPLAINT: INSERTION PIN OF THE DRAINAGE SYSTEM CANNOT BE INSERTED INTO THE CATHETER VALVE. ADDITIONAL INFORMATIONS: DESCRIPTION OF ISSUE (WHAT / WHY): INSERTION PIN OF THE DRAINAGE SYSTEM CANNOT BE INSERTED INTO THE CATHETER VALVE. HOW OFTEN OCCURED DEFECT: ONCE MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO NEEDLE/PROBE STICK: NO OTHER ACTIONS TAKEN: NO SAFETY ISSUE: NO ISSUE RESOLVED: YES HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE PHOTO / SAMPLE AVAILABLE: NO SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: YES SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO SAFETY VALVE NOSE BROKEN / DAMAGED: NO LOCKING TAB BROKEN / DAMAGED: NO LEAKAGE: YES SUCCESSFUL DRAINAGE: YES IMPACT TO PATIENT: NO IMPACT TO PATIENT EXPOSURE TO BLOOD / BODILY FLUID: NO COURSE OF TREATMENT CHANGED DUE TO EVENT: NO TIME CATHETER IN PLACE: (B)(6) 2024. CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-9050A PROCEDURE PERFORMED BY: NURSE PROCEDURE PERFORMED AT: HOSPITAL REPLACEMENT REQUESTED: NO CREDIT REQUESTED: YES ADDITIONAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223524 ↗
• MalfunctionDec 3, 2024Break; Break

  INJURY (PATIENT/OTHER): NO. DEVICE POSSIBLY INVOLVED IN INJURY: NO. DEVICE AVAILABLE FOR EXAMINATION: YES. COMPLAINT: VALVE LEAKING. AFFECTED COMPONENT ARTICLE NO.: / -. AFFECTED COMPONENT LOT NO.: ADDITIONAL INFORMATIONS: DESCRIPTION OF ISSUE (WHAT / WHY): VALVE LEAKING. HOW OFTEN OCCURED DEFECT: ONCE. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER ACTIONS TAKEN: NO. SAFETY ISSUE: NO. ISSUE RESOLVED: YES. HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE. PHOTO / SAMPLE AVAILABLE: YES. SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: YES. SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO. SAFETY VALVE NOSE BROKEN / DAMAGED: NO. LOCKING TAB BROKEN / DAMAGED: NO. LEAKAGE: YES. SUCCESSFUL DRAINAGE: YES. IMPACT TO PATIENT: NO IMPACT TO PATIENT. EXPOSURE TO BLOOD / BODILY FLUID: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. TIME CATHETER IN PLACE: (B)(6) 2023. CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-9050A. PROCEDURE PERFORMED BY: EWIMED EMPLOYEE. PROCEDURE PERFORMED AT: HOME. REPLACEMENT REQUESTED: NO. CREDIT REQUESTED: YES. ADDITIONAL INFORMATION: INFORMATION ON THE DEFECT: DEFECT LOCATION: VALVE. DEFECT TYPE: LEAKING. (B)(6) 2024:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833995 ↗
• MalfunctionNov 22, 2024Break; Break

  INJURY (PATIENT / OTHER): NO. PRODUCT POSSIBLE INVOLVED IN INJURY: NO. PRODUCT AVAILABLE FOR INQUIRY: NO. COMPLAINT: VALVE LEAKING. PRODUCT: ADDITIONAL INFORMATIONS: DESCRIPTION OF ISSUE (WHAT / WHY): VALVE LEAKING. HOW OFTEN OCCURED DEFECT: ONCE. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER ACTIONS TAKEN: NO. SAFETY ISSUE: NO. ISSUE RESOLVED: YES. HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE. PHOTO / SAMPLE AVAILABLE: NO. SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: YES. SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO. SAFETY VALVE NOSE BROKEN / DAMAGED: NO. LOCKING TAB BROKEN / DAMAGED: NO. LEAKAGE: YES. SUCCESSFUL DRAINAGE: YES. IMPACT TO PATIENT: NO IMPACT TO PATIENT. EXPOSURE TO BLOOD / BODILY FLUID: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. TIME CATHETER IN PLACE: (B)(6) 2023. CONNECTED DEVICE (PLEURX/PERITX/BRAND): 50-9050A. PROCEDURE PERFORMED BY: (B)(6) EMPLOYEE. PROCEDURE PERFORMED AT: HOSPITAL. REPLACEMENT REQUESTED: NO. CREDIT REQUESTED: YES. CLOSURE LETTER NEEDED: YES. INFORMATION ON THE ERROR PATTERN: FAULT LOCATION: VALVE. ERROR TYPE: LEAKY. RESPONSE RECEIVED ON 14-NOV-2024: NOT KNOWN. WAS THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20761269 ↗
• MalfunctionNov 22, 2024Break; Break

  INJURY (PATIENT / OTHER): NO DEVICE POSSIBLY INVOLVED IN INJURY: NO DEVICE AVAILABLE FOR EXAMINATION: YES; YES LOCATION: 2 - DURING APPLICATION ORIGIN: RELATIVE COMPLAINT: VALVE LEAKING. ADDITIONAL INFORMATION: DESCRIPTION OF ISSUE (WHAT / WHY): VALVE LEAKING HOW OFTEN OCCURRED DEFECT: ONCE MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO NEEDLE/PROBE STICK: NO OTHER ACTIONS TAKEN: NO SAFETY ISSUE: NO ISSUE RESOLVED: YES HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE PHOTO / SAMPLE AVAILABLE: NO SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: YES SAFETY CLAMP OPEN WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO SAFETY VALVE NOSE BROKE/DAMAGED: NO LOCKING TAB BROKE/DAMAGED: NO LEAKAGE: YES SUCCESSFUL DRAINAGE: YES IMPACT TO PATIENT: NO IMPACT TO PATIENT EXPOSURE TO BLOOD/BODILY FLUID: NO COURSE OF TREATMENT CHANGED DUE TO EVENT: NO TIME CATHETER IN PLACE: 06.09.2024 CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-9050A PROCEDURE PERFORMED BY: EWIMED EMPLOYEE PROCEDURE PERFORMED AT: HOME REPLACEMENT REQUESTED: NO CREDIT REQUESTED: YES CLOSURE LETTER NEEDED: YES ADDITIONAL INFORMATION: INFORMATION ON THE ERROR: ERROR LOCATION: VALVE ERROR TYPE: LEAKING RESPONSE RECEIVED: 22-NOV-2024 AS PE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759030 ↗
• MalfunctionNov 21, 2024Break; Break

  INJURY (PATIENT / OTHER): NO. DEVICE POSSIBLY INVOLVED IN INJURY: NO. DEVICE AVAILABLE FOR INVESTIGATION: YES. PLACE WHERE NOTICED: 2 - DURING USE. ORIGIN: PATIENT. COMPLAINT: VALVE DEFECT 10 DAYS AFTER IMPLANTATION WITHOUT EXTERNAL INFLUENCE AND REGULAR USE. ADDITIONAL INFORMATION: DESCRIPTION OF THE PROBLEM (WHAT/WHY): VALVE DEFECT. HOW OFTEN DID THE DEFECT OCCUR: ONCE. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLESTICK/PROBE STICK: NO. OTHER MEASURES: NO. SAFETY ISSUE: NO. PROBLEM RESOLVED: YES. HOW WAS THE PROBLEM RESOLVED/ADDITIONAL INFORMATION: VALVE CHANGE PHOTO/SAMPLE AVAILABLE: YES. SAFETY VALVE BROKEN/DAMAGED/DISCONNECTED: YES. SAFETY CLAMP OPEN WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO. SAFETY VALVE NOSE BROKEN/DAMAGED: NO. SAFETY TAB BROKEN/DAMAGED: NO. LEAKAGE: YES. SUCCESSFUL DRAINAGE: YES. PATIENT IMPACT: NO IMPACT ON PATIENT BLOOD/BODY FLUID CONTACT: NO. TREATMENT CHANGED DUE TO INCIDENT: NO. TIME OF CATHETER INSERTION: ON (B)(6) 2024. DEVICE ATTACHED (PLEURX/PERITX/BRAND) 50-9050A. PERFORMED BY: EWIMED EMPLOYEE. PERFORMED IN: HOME. ERROR DESCRIPTION: ERROR LOCATION: VALVE. ERROR TYPE: DAMAGED (BROKEN, BRITTLE, DEFORMED). ADDITIONALLY AFFECTED LOT NOS.: 00

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747876 ↗
• MalfunctionNov 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  INJURY (PATIENT / OTHER): NO. PRODUCT POSSIBLE INVOLVED IN INJURY: NO. PRODUCT AVAILABLE FOR INQUIRY: NO. LOCATION:2 - WHEN USING. ORIGIN: PATIENT. COMPLAINT: VALVE LEAKING LIQUID LEAKING OUT ADDITIONAL INFORMATION: DESCRIPTION OF ISSUE (WHAT / WHY): VALVE LEAKING HOW OFTEN OCCURED DEFECT: ONCE MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO NEEDLE/PROBE STICK: NO OTHER ACTIONS TAKEN: NO SAFETY ISSUE: NEIN ISSUE RESOLVED: YES HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE PHOTO / SAMPLE AVAILABLE: NO SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: YES SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO SAFETY VALVE NOSE BROKEN / DAMAGED: NO LOCKING TAB BROKEN / DAMAGED: NO LEAKAGE: NO SUCCESSFUL DRAINAGE: JA IMPACT TO PATIENT: NO INDICATION FOR THAT / NOT APPLICABLE EXPOSURE TO BLOOD / BODILY FLUID: NO COURSE OF TREATMENT CHANGED DUE TO EVENT: NO TIME CATHETER IN PLACE: (B)(6) 2022 CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-9050A PROCEDURE PERFORMED BY: EWIMED EMPLOYEE PROCEDURE PERFORMED AT: HOME REPLACEMENT REQUESTED: NO CREDIT REQUESTED: JA CLOSURE LETTER NEDDED: YES ADDITIONAL INFORMATION: ADDITIONAL INFORMATION: INFORMATION ON THE ERROR PATTERN: FAULT LOCATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641950 ↗
• MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  INJURY (PATIENT / OTHER): NO. PRODUCT POSSIBLE INVOLVED IN INJURY: NO. PRODUCT AVAILABLE FOR INQUIRY: YES. COMPLAINT: VALVE LEAKING LIQUID LEAKING OUT. ADDITIONAL INFORMATIONS: DESCRIPTION OF ISSUE (WHAT / WHY): VALVE LEAKING. HOW OFTEN OCCURED DEFECT: ONCE. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER ACTIONS TAKEN: NO. SAFETY ISSUE: NO. ISSUE RESOLVED: YES HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE. PHOTO / SAMPLE AVAILABLE: NO. SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: YES. SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NO. SAFETY VALVE NOSE BROKEN / DAMAGED: NO. LOCKING TAB BROKEN / DAMAGED: NO. LEAKAGE: NO. SUCCESSFUL DRAINAGE: YES. IMPACT TO PATIENT: NO INDICATION FOR THAT / NOT APPLICABLE. EXPOSURE TO BLOOD / BODILY FLUID: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. TIME CATHETER IN PLACE: (B)(6) 2024 CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-9050A. PROCEDURE PERFORMED BY: (B)(6) . PROCEDURE PERFORMED AT: HOME. REPLACEMENT REQUESTED: NO. CREDIT REQUESTED: AND. CLOSURE LETTER NEEDED: YES. ADDITIONAL INFORMATION: INFORMATION ON THE ERROR PATTERN: FAULT LOCATION: VALVE. ERROR TYPE: LEAKY. RESPONSE RECEIVED ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516247 ↗
• MalfunctionOct 15, 2024Break; Break

  PLEURX SAFETY VALVE WAS NOT WORKING ITS GOT DAMAGE AFTER PLACEMENT. ON (B)(6) 2024- RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION REQUESTED. REFER EMAIL ATTACHED. (B)(6). PATIENT CONDITION WAS NOT GOOD AT PRESENT AS I DISCUSSED WITH KOL. WHEN HI INSERTED THE CATHETER DRAINAGE PROPERLY. ON (B)(6) 2024- RECEIVED AN EMAIL RESPONSE FROM COMPLAINANT FOR INFORMATION REQUESTED. CURRENT PATIENT CONDITION IS NOT GOOD. HI IS SERIOUS AFTER PLEURX PLACEMENT. OUR CONSULT IS VERY ANNOYED.

  Patient problems: Insufficient Information

  MAUDE report 20453795 ↗
• MalfunctionAug 30, 2024Break; Break

  INJURY (PATIENT / OTHER): NO. DEVICE POSSIBLY INVOLVED IN INJURY: NO. DEVICE AVAILABLE FOR EXAMINATION: YES. DETECTION SITE: 2 - ON APPLICATION. ORIGIN: PATIENT. COMPLAINT: PEEL-AWAY INTRODUCER DAMAGED. PRODUCT INFORMATION: ITEM NO: 50-9050A/V001 - PERITX¿ ASCITES CATHETER. ADDITIONALLY AFFECTED ARTICLE NO: 50-9050A/V001 - PERITX¿ ASCITES CATHETER. ADDITIONALLY AFFECTED LOT NO.: 0001500128. ADDITIONAL INFORMATION: DESCRIPTION OF ISSUE (WHAT / WHY): PEEL-AWAY INTRODUCER DAMAGED. HOW OFTEN DEFECT OCCURRED: 2. MEDICAL INTERVENTION (OTHER THAN FIRST AID): NO. NEEDLE/PROBE STICK: NO. OTHER ACTIONS TAKEN: NO. SAFETY ISSUE: NO. ISSUE RESOLVED: YES. HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: REPLACEMENT. PHOTO / SAMPLE AVAILABLE: YES. IMPACT TO PATIENT: NO INDICATION FOR THAT / NOT APPLICABLE. EXPOSURE TO BLOOD / BODILY FLUID: NO. COURSE OF TREATMENT CHANGED DUE TO EVENT: NO. PROCEDURE PERFORMED BY: PHYSICIAN. PROCEDURE PERFORMED AT: HOSPITAL. REPLACEMENT REQUESTED: NO. CREDIT REQUESTED: YES. CLOSURE LETTER NEEDED: YES. ADDITIONAL INFORMATION: INFORMATION ON THE ERROR PATTERN: ERROR LOCATION: SPLIT LOCK. TYPE OF FAULT: DAMAGED (BROKEN, BRITTLE, DEFORMED). WAS THE DAMAGED PEEL-AWAY INTROD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20112228 ↗
• MalfunctionAug 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING THE IMPORT INSPECTION OF BD-047, SOME CRUSHED BOXES WERE IDENTIFIED. ITEM C08293 - 50-9050A CAME MISSING 3 BOXES ((B)(4) UNITS), IN ADDITION TO (B)(4) UNITS OF THE SAME ITEM WITH DAMAGES. ADDITIONAL INFORMATION RECEIVED ON 19 AUG 2024: PLEASE INDICATE THE NUMBER OF CRUSHED BOXES. 2 BOXES. ADDITIONAL INFORMATION RECEIVED ON 21 AUG 2024: WAS THE PERITX CATHETER KIT/TRAY DAMAGED DURING TRANSPORTATION? WE ARE UNABLE TO SAY WHEN THE PRODUCTS WERE DAMAGED, WHETHER IT OCCURRED DURING TRANSPORTATION OR IF THEY LEFT THE FACTORY THAT WAY. IF SO, WHAT IS THE TOTAL NUMBER OF OCCURRENCES/QUANTITIES ASSOCIATED WITH DAMAGED TRAYS? DAMAGED TRAYS: (B)(4) UNITS. MISSING TRAYS: (B)(4) UNITS (3 BOXES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20108983 ↗
• MalfunctionAug 5, 2024Break; Break

  INJURY (PATIENT / OTHER): NO, DEVICE POSSIBLY INVOLVED IN INJURY: NO. COMPLAINT: VALVE LEAKING PRODUCT INFORMATION: ARTICLE NO: 50-9050A/V001 - PERITX¿ ASCITES CATHETER ADDITIONALLY AFFECTED ARTICLE NO: 50-9050A/V001 - PERITX¿ ASCITES CATHETER. ADDITIONAL INFORMATION: DESCRIPTION OF ISSUE (WHAT / WHY): VALVE LEAKING, HOW OFTEN OCCURED DEFECT: ONCE, MEDICAL INTERVENTION (OTHER THAN FIRST AID): NEIN, NEEDLE/PROBE STICK: NEIN, OTHER ACTIONS TAKEN: NEIN, SAFETY ISSUE: NEIN, ISSUE RESOLVED: JA. HOW ISSUE RESOLVED / ADDITIONAL INFORMATION: VALVE CHANGE PHOTO / SAMPLE AVAILABLE: JA, SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED: JA, SAFETY CLAMP OPEN, WHEN VALVE BROKE/DAMAGED/DISCONNECTED: NEIN, SAFETY VALVE NOSE BROKEN / DAMAGED: NEIN, LOCKING TAB BROKEN / DAMAGED: NEIN, LEAKAGE: JA, SUCCESSFUL DRAINAGE: JA. IMPACT TO PATIENT: NO IMPACT TO PATIENT. EXPOSURE TO BLOOD / BODILY FLUID: NEIN. COURSE OF TREATMENT CHANGED DUE TO EVENT: NEIN. TIME CATHETER IN PLACE: ON (B)(6) 2021. CONNECTED DEVICE (PLEURX/PERITX/BRAND) 50-9050A. PROCEDURE PERFORMED BY: EWIMED EMPLOYEE. PROCEDURE PERFORMED AT: HOME. REPLACEMENT REQUESTED: NEIN. CREDIT REQUESTED: JA. ADDITIONAL INFORMATION: INFORMATION ON THE FAUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19914721 ↗