Safe-T-Centesis PIG1260TRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10885403108365), received between Nov 10, 2020 and Sep 22, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 6, 2025Open, Classified

   Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.

   Z-0887-2026 · Root cause: Process control · FDA record ↗

2. May 28, 2020Terminated

   The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

   Z-2648-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862899 ↗
• MalfunctionAug 20, 2026Gas/Air Leak

  It was reported that during use of Safe T Centesis tray, the APP connected the tubing to the catheter and turns it on the system however, fluid backed up instead of flowing as intended. During follow-up response received on (b)(6)2026, it was reported that the issue was observed on two separate occasions after fluid had been aspirated into a syringe for laboratory testing and the system was connected to a gravity drain. At that time, a hissing sound indicating air escape was heard when connected to the vacuum bottle. Fluid was observed moving back toward the patient through the tubing; however, the user stopped the three-way stopcock before all of the fluid could return. No visible blockage, kinks, clamps, or obstructions were identified, and no damage was observed on the catheter, tubing, connectors. The procedure was being performed using a 6Fr Safe-T-Centesis catheter, and all connections were reported to be secure and properly assembled. The issue was not resolved by replacing any components; instead, water was added to the white hub to create a water seal and address a potential air leak. No medical intervention, treatment delay, or patient harm was reported, although the issu

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349876 ↗
• MalfunctionAug 20, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50349399 ↗
• MalfunctionJul 27, 2026Complete Blockage

  It was reported during customer follow up response on July 04, 2026, that a similar incident occurred with date of event of (B)(6) 2026. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50046554 ↗
• MalfunctionJun 30, 2026Complete Blockage

  IT WAS REPORTED THAT WHEN THE NEEDLE WAS INSERTED THERE WAS NO ASCITES FLUID COMING OUT THROUGH THE CATHETER, BUT WHEN THE CATHETER SYSTEM WAS REMOVED FROM THE NEEDLE, ASCITES FLUID CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666723 ↗
• MalfunctionJun 29, 2026Complete Blockage

  IT WAS REPORTED BY A TRAUMA INTENSIVE CARE UNIT (TICU) PHYSICIAN ASSISTANT (PA) THAT THERE WAS AN ISSUE WITH THE SAFE-T-CENTESIS DRAINAGE TRAY. THE PA STATED THAT WHEN THE NEEDLE WAS INSERTED, NO ASCITIC FLUID COMES OUT THROUGH THE CATHETER SYSTEM; HOWEVER, ONCE THE CATHETER SYSTEM WAS REMOVED FROM THE NEEDLE, ASCITIC FLUID WAS OBSERVED TO FLOW.

  Patient problems: Insufficient Information

  MAUDE report 25662094 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE THORACENTESIS LINE FAILURE AT THE STOPCOCK, VALVE CAUSING A BLOCKAGE DUE TO BROKEN PRODUCT. DURING FOLLOW UP ADDITIONAL INFORMATION RECEIVED ON MONDAY, (B)(6), 2026, IT WAS FURTHER REPORTED THAT THE THORACENTESIS LINE FAILURE AT STOPCOCK VALVE CAUSING A BLOCKAGE DUE TO BROKEN PRODUCT; HOWEVER, THE SPECIFIC COMPONENT THAT FAILED COULD NOT BE IDENTIFIED. THERE WAS NO REPORTED OR CONFIRMED IMPACT TO A PATIENT, HEALTHCARE PROVIDER, OR USER, AND NO MEDICAL INTERVENTION, DIAGNOSTIC ACTION, OR TREATMENT DELAY WAS DOCUMENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905951 ↗
• InjuryNov 12, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT WHEN SPEAKING TO OTHER COLLEAGUES ON THE INTERVENTIONAL PULMONOLOGY TEAM A SIMILAR DEFECTS HAVE BEEN CORROBORATED RECENTLY.

  Patient problems: Pneumothorax

  MAUDE report 23532747 ↗
• InjuryNov 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS INITIALLY REPORTED THAT THE SAFE-T-CENTESIS CATHETER DRAINAGE SYSTEM DID NOT FUNCTION AS INTENDED DURING A DIAGNOSTIC THORACENTESIS PROCEDURE. INITIALLY, THE CUSTOMER STATED THAT THERE WERE NO INJURIES OR ADVERSE EVENTS ASSOCIATED WITH THE COMPLAINT. DURING FOLLOW-UP WITH THE FACILITY, IT WAS CLARIFIED THAT THE SAFE-T-CENTESIS NEEDLE WAS INTRODUCED WITH POSITIVE FLUID RETURN, AND THE CATHETER WAS ADVANCED. UPON INITIATING MANUAL ASPIRATION, AIR WAS UNEXPECTEDLY ASPIRATED FROM THE CATHETER. THE SYSTEM ONLY ASPIRATED FLUID WHEN THE WHITE MEMBRANE AREA WAS MANUALLY OCCLUDED; OTHERWISE, AIR ENTERED THE CATHETER, PRODUCING AN AUDIBLE HISS. SUCTION WAS COMPLETED WHILE MAINTAINING OCCLUSION OF THE ONE-WAY MEMBRANE, AND THE CATHETER WAS REMOVED. A FOLLOW-UP CHEST X-RAY REVEALED A LOCULATED HYDRO-PNEUMOTHORAX. THE PATIENT REMAINED UNDER SUPERVISION FOR ADDITIONAL IMAGING.

  Patient problems: Pneumothorax

  MAUDE report 23501364 ↗
• MalfunctionJul 11, 2025Contamination; Contamination

  IT WAS REPORTED THAT A HAIR WAS IDENTIFIED WRAPPED AROUND ONE OF THE CHLORAPREP SWABS OF THE SAFE-T-CENTESIS TRAY AND THAT IT IS BELIEVED IT WAS NOT USED. ANOTHER KIT WAS USED TO RESOLVE THE ISSUE AND TREAT THE PATIENT SUCCESSFULLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485401 ↗
• MalfunctionApr 25, 2025Contamination; Contamination

  IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND ON THE NEEDLE TIP OF THE SAFE-T-CENTESIS TRAY KIT WHEN IT WAS PUSHED THROUGH THE CATHETER. IT WAS FURTHER REPORTED THAT THE CATHETER WAS DIFFICULT TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911568 ↗
• InjuryApr 4, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE SAFE T CENTESIS KITS- LAWSON 218295 HAVE STARTED CONTAINING A DIFFERENT VIAL OF LIDOCAINE. THE VIAL HAS SHATTERED WHEN OPENING ON MULTIPLE OCCASIONS CAUSING LACERATIONS ON 2 EMPLOYEES AND CUTTING GLOVES. THE KITS ARE ALSO RENDERED UNUSABLE WHEN THIS HAPPENS BECAUSE OF GLASS ACROSS THE FIELD. QUOTE FROM CUSTOMER- THE SAF T CENTESIS KITS- LAWSON 218295 HAVE STARTED CONTAINING A DIFFERENT VIAL OF LIDOCAINE. THE VIAL HAS SHATTERED WHEN OPENING ON MULTIPLE OCCASIONS CAUSING LACERATIONS ON 2 EMPLOYEES AND CUTTING GLOVES. THE KITS ARE ALSO RENDERED UNUSABLE WHEN THIS HAPPENS BECAUSE OF GLASS ACROSS THE FIELD. SAF-T- CENTESIS KIT LOT: 0001589013.

  Patient problems: Laceration(s)

  MAUDE report 21773893 ↗
• InjuryApr 4, 2025Break; Break

  IT WAS REPORTED BY CUSTOMER THAT THE SAFE T CENTESIS KITS HAVE STARTED CONTAINING A DIFFERENT VIAL OF LIDOCAINE. THE VIAL HAS SHATTERED WHEN OPENING ON MULTIPLE OCCASIONS CAUSING LACERATIONS ON 2 EMPLOYEES AND CUTTING GLOVES. THE KITS ARE ALSO RENDERED UNUSABLE WHEN THIS HAPPENS BECAUSE OF GLASS ACROSS THE FIELD.

  Patient problems: Laceration(s)

  MAUDE report 21773886 ↗
• MalfunctionJan 17, 2025Break; Contamination; Break; Contamination

  MATERIAL # PIG1260T, BATCH # 0001561282. IT WAS REPORTED BY CUSTOMER THAT UPON OPENING THE KIT, A SMALL FIBER OF BLACK HAIR WAS ATTACHED TO THE STERILE GAUZE INSIDE THE TRAY. THERE WAS NO REPORTED PATIENT CONTACT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE WERE 5 AFFECTED PIG1260T WITH THE SAME LOT CODE# 0001563639, BUT ONLY TWO WERE SAVED AND SET ASIDE. IN ADDITION, I HAVE RECEIVED TWO MORE AFFECTED PIG1260T WITH A DIFFERENT LOT CODES. LIST OF AFFECTED LOT CODE: 0001561282 X 1, 0001571284 X1, 0001563639 X2. ADDITIONAL INFORMATION RECEIVE ON 26DEC. SAFE-T-CENTESIS 6 FR CATHETER DRAINAGE TRAY; CAREFUSION, LOT #: 0001561282, EXP: 08-31-2026. DURING THORACENTESIS PROCEDURE WITH PATIENT XXX, MRN (B)6), ON (B)(6) 2024 IN PREPARATION OF CENTESIS TRAY, MD FOUND A SMALL FIBER OF BLACK HAIR ATTACHED TO STERILE GAUZE INSIDE TRAY UPON OPENING THE KIT. MD AND NURSE THREW AWAY AFFECTED TRAY AND OPENED NEW KIT TO RESUME PROCEDURE IN STERILE MANNER. PHOTOS TAKEN AND SENT TO PROCEDURE CENTER MANAGEMENT FOR FURTHER EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 14JAN 1. WAS THERE ANY VISIBLE DEFECT NOTICEABLE TO THE PRODUCT BOXES OR THE PACKAGING? IF YES, PLEASE SPECIFY. 2. DID THE DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186071 ↗
• MalfunctionDec 4, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER THAT AIR LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CAT. PIG1260T. SAFE-T-CENTESIS. 6 FR CATHETER DRAINAGE TRAY. LOT # 0001576845. PROBLEM: AIR LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 20844442 ↗
• MalfunctionNov 22, 2024Gas/Air Leak; Gas/Air Leak

  MATERIAL # PIG1260T BATCH # 0001578957 IT WAS REPORTED BY CUSTOMER THAT THERE IS AIR LEAK, DEFECTIVE/HISSING. VERBATIM: MFR # PIG1260T LOT # 0001578957 DEFECTIVE/HISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20765911 ↗
• MalfunctionNov 22, 2024Gas/Air Leak; Gas/Air Leak

  MATERIAL # PIG1260T BATCH # 0001574753 IT WAS REPORTED BY CUSTOMER THAT THERE IS AIR LEAK, DEFECTIVE/HISSING. VERBATIM:  MFR # PIG1260T    LOT # 0001574753  DEFECTIVE/HISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20765096 ↗
• MalfunctionNov 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER THAT THERE IS AIR LEAK, DEFECTIVE/HISSING. VERBATIM: MFR # PIG1260T; LOT # 0001576845; DEFECTIVE/HISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20764258 ↗
• MalfunctionNov 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE DEFECTIVE TRAY DIAPHRAGM ON THE CATHETER WAS LEAKING. THERE WAS NO PATIENT HARM. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INITIALLY WHEN I EMAILED XXX, I HAD RECEIVED TWO COMPLAINTS REGARDING ITEM # PIG1260T, BOTH WERE LEAKING ISSUES ("DEFECTIVE SUCTION TUBE LEAKS AIR" AND "DEFECTIVE TRAY DIAPHRAGM ON CATHETER LEAKING"). THE LOT # FOR THE ONE PACKAGE I HAVE IS 0001574753, THIS WEEK I RECEIVED NOTICE THAT THERE HAVE BEEN POTENTIALLY 7 MORE QUALITY ISSUES WITH THE SAME PRODUCT, NOT SURE OF THE LOT # BECAUSE I DON'T HAVE THOSE PACKAGES YET. AS FAR AS I KNOW, THEY DID NOT KEEP THE PRODUCT ITSELF; I HAVE SINCE INSTRUCTED THEM TO DO THEIR BEST TO KEEP THE PRODUCT. I WASN'T SURE OF THE NEXT STEPS WITH THIS CONCERN. CUSTOMER RESPONSE ON (B)(6) 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR BOTH ISSUES "DEFECTIVE SUCTION TUBE LEAKS AIR" AND "DEFECTIVE TRAY DIAPHRAGM ON CATHETER LEAKING"? BOTH ISSUES OCCURRED ON (B)(6) 2024. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM RESULTED FROM FAULTY CATHETER. THE PROBLEM IS AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679209 ↗
• MalfunctionNov 13, 2024Gas/Air Leak; Gas/Air Leak

  MATERIAL#: PIG1260T, BATCH#: 0001574753. IT WAS REPORTED BY CUSTOMER THAT THE DEFECTIVE SUCTION TUBE LEAKS AIR FROM THE DIAPHRAGM ON THE CATHETER. THERE WAS NO PATIENT HARM DUE TO THE FAULTY CATHETER. RCC RECEIVED A COMPLAINT VIA EMAIL. INITIALLY WHEN I EMAILED, I HAD RECEIVED TWO COMPLAINTS REGARDING ITEM#: PIG1260T, BOTH WERE LEAKING ISSUES ("DEFECTIVE SUCTION TUBE LEAKS AIR" AND "DEFECTIVE TRAY DIAPHRAGM ON CATHETER LEAKING"). THE LOT# FOR THE ONE PACKAGE I HAVE IS 0001574753, THIS WEEK I RECEIVED NOTICE THAT THERE HAVE BEEN POTENTIALLY 7 MORE QUALITY ISSUES WITH THE SAME PRODUCT, NOT SURE OF THE LOT# BECAUSE I DON'T HAVE THOSE PACKAGES YET. AS FAR AS I KNOW, THEY DID NOT KEEP THE PRODUCT ITSELF; I HAVE SINCE INSTRUCTED THEM TO DO THEIR BEST TO KEEP THE PRODUCT. I WASN'T SURE OF THE NEXT STEPS WITH THIS CONCERN. CUSTOMER RESPONSE ON NOVEMBER 15, 2024. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR BOTH ISSUES "DEFECTIVE SUCTION TUBE LEAKS AIR" AND "DEFECTIVE TRAY DIAPHRAGM ON CATHETER LEAKING"? BOTH ISSUES OCCURRED ON 10/15/2024. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678360 ↗
• InjuryAug 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER THAT VALVE (NEEDLE ENTRY POINT) LEAKING AIR DURING THORACENTESIS PROCEDURE. CAUSED SMALL PNEUMOTHORAX, BUT THEY WERE ABLE TO REMOVE AIR WITH VACUUM BOTTLE DURING PLEURAL FLUID DRAINAGE. THEY DETERMINED IT WAS THE VALVE AREA BY PUTTING THEIR FINGER OVER THE HUB AND AIR STOPPED. VERBATIM: PIG1260T - VALVE (NEEDLE ENTRY POINT) LEAKING AIR DURING THORACENTESIS PROCEDURE. CAUSED SMALL PNEUMOTHORAX, BUT THEY WERE ABLE TO REMOVE AIR WITH VACUUM BOTTLE DURING PLEURAL FLUID DRAINAGE. THEY DETERMINED IT WAS THE VALVE AREA BY PUTTING THEIR FINGER OVER THE HUB AND AIR STOPPED. NO HARM TO PATIENT, BUT DID HAVE SMALL AMOUNT OF AIR LEFT, BUT AFTER A SCAN OF THE LUNG SPACE, THE PHYSICIAN DETERMINED IT WOULD RESOLVE ON ITS OWN. LOT#0001569882 CUSTOMER RESPONSE ON (B)(6) 2024 THIS PATIENT WAS IN OUR DEPARTMENT FOR A RIGHT THORACENTESIS. THE CENTESIS CATHETER WAS INSERTED BY OUR PA. AFTER THE CATHETER WAS INSERTED, I NOTICED BUBBLES MIXING WITH FLUID IN THE DRAINAGE TUBING AND COULD HEAR A SLIGHT HISSING SOUND COMING FROM THE CATHETER. UPON INVESTIGATION, I DETERMINED THE SOUND WAS COMING FROM THE VALVE AND THE NOISE STOPPED ONCE I PLACED MY FINGER OVER THE VALVE. A 1-LITE

  Patient problems: Pneumothorax

  MAUDE report 20108372 ↗
• MalfunctionAug 15, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED BY CUSTOMER THAT THEY HAVE AN AIR LEAK IN THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. REPORTED ISSUE: WE HAD AN EVENT THIS MORNING WHERE WE SEEMED TO HAVE AN AIR LEAK IN THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. CUSTOMER RESPONSE RECEIVED ON 07AUG: 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? - PT. CAME IN FOR A PARACENTESIS. ONCE PHYSICIAN INSERTED THE DEVICE, THERE SEEMED TO BE AN AIR LEAK, WHERE ARE WAS GETTING INTO THE TUBING AND INTO THE EVAC CONTAINER. THE AIR LEAKED APPEARED TO BE COMING AT OF THE WHITE CONNECTOR WHERE THE NEEDLE IS REMOVED AFTER INSERTED. THE PRODUCT USED WAS SAFE-T-CENTESIS 6 FR CATHETER DRAINAGE TRAY LOT NO. 0001548376. THIS CAUSED THE PROCEDURE TO TAKE LONGER. 2. DID THE ISSUE HAPPEN DURING PATIENT USE AND THE PRODUCT DISCARDED OR DID THEY IDENTIFY THE AIR LEAKAGE DURING USE? ¿ DURING USE ¿ PRODUCT RETURNED TO VENDOR PER YOUR REQUEST. 3. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? ¿ DIRECTLY. 4. WHAT WAS THE IMPACT TO THE PATIENT? ¿ LONGER PROCEDURE TIME. 5. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? ¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990967 ↗
• InjuryJun 26, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED BY CUSTOMER THAT THEY HAD AN ISSUE WITH SAFE-T-CENTESIS 6FR CATHETER DRAINAGE TRAY, IT DID RESULT IN A PNEUMO. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAD AN ISSUE WITH SAFE-T-CENTESIS 6FR CATHETER DRAINAGE TRAY, IT DID RESULT IN A PNEUMO. CUSTOMER RESPONSE ON (B)(6) 2024. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? THE BLUE HUB DISCONNECTED FROM THE REST OF THE VALVE TUBING CONSTRUCT WHEN REMOVING THE CATHETER FROM THE PATIENT. THIS RESULTED IN THE CATHETER REMAINING IN THE PATIENT. THE CATHETER WAS THEN REMOVED SEPARATELY WITHIN SECONDS OF BEING DISCONNECTED. HOWEVER, WITHIN THAT SHORT AMOUNT OF TIME, AIR ENTERED INTO THE PLEURAL SPACE, WHICH WAS SEEN AS A PNEUMOTHORAX ON CXR POST-PROCEDURE. PLEASE SPECIFY DEVICE FAILURE. BLUE HUB DISCONNECTED FROM THREADED CONNECTION THE VALVE TUBING CONSTRUCT. IT IS A SCREW IN/THREADED CONNECTION. IT MOST LIKELY WAS NOT COMPLETELY THREADED TOGETHER. WHAT WAS THE IMPACT ON THE PATIENT? PNEUMOTHORAX. DID THE PATIENT HAVE A PNEUMOTHORAX DUE TO A DEVICE MALFUNCTION? PNEUMOTHORAX AS SEEN ON CXR. WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? NO FURTHER INT

  Patient problems: Pneumothorax

  MAUDE report 19614221 ↗
• MalfunctionApr 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED BY CUSTOMER THAT THE BXT PIG1260T THAT WAS DEFECTIVE. THE HUB WHERE THE NEEDLE COMES OUT WAS LEAKING AND SUCKS AIR (SUPPOSED TO BE A CLOSED VALVE). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: (B)(4), QUANTITY AFFECTED: (B)(4) EA, SERIAL/LOT NUMBER: (B)(6). REPORTED ISSUE PER CUSTOMER: 3/19/2024 XXXXXX REPORTS THAT THEY HAD 1 EA BXT PIG1260T THAT WAS DEFECTIVE. THE HUB WHERE THE NEEDLE COMES OUT WAS LEAKING AND SUCKS AIR (SUPPOSED TO BE A CLOSED VALVE). LOT #0001548326, EXP DATE 2026-01-31. CUSTOMER HAS SAMPLE TO SEND IN. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080239 ↗
• InjuryMar 11, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY CUSTOMER THAT STAFF HAVE REPORTED TO THEM THAT WHEN TRYING TO OPEN THE GLASS LIDOCAINE AMPULES, THE GLASS CUTS THEM OR RIPS THE STERILE GLOVE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I¿M REACHING OUT TO YOU REGARDING THE BD SAFE-T-CENTESIS TRAYS (CATALOG PIG1260T). RECENTLY STAFF HAVE REPORTED TO US THAT WHEN TRYING TO OPEN THE GLASS LIDOCAINE AMPULES, THE GLASS CUTS THEM OR RIPS THE STERILE GLOVE. PRODUCT#: PIG1260T.

  Patient problems: Needle Stick/Puncture

  MAUDE report 18881941 ↗