Alaris 10800175Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10885403234408), received between Oct 31, 2018 and Mar 13, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (22 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Fluid/Blood Leak

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598409 ↗
• MalfunctionFeb 19, 2026Crack; Leak/Splash

  A CRACK IN THE PRIMARY EXTENSION SET. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392218 ↗
• MalfunctionOct 21, 2025Infusion or Flow Problem; Infusion or Flow Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349522 ↗
• MalfunctionJun 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PCA ADMINISTRATION KIT LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT CALLED IN THE NURSE TO THEIR ROOM TO ADVISE HER ¿IV WAS LEAKING.¿ NURSE NOTICED THAT ON THE PCA TUBING, THE ROUND WHITE PIECE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157846 ↗
• MalfunctionMar 31, 2025Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION KIT BROKE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM BD PCA TUBING REF 10800175- THEY COULD NOT REMOVE THE WHITE CAP. WHEN THEY TIRED AGAIN THE TIP OF THE WHITE CAP BROKE OFF INTO THE PCA TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21735543 ↗
• MalfunctionNov 21, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION KIT WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: WHEN CHECKING A NEW PCA SYRINGE AND TUBING THE TUBING TIP SNAPPED OFF INTO THE PCA SYRINGE AND WAS NO LONGER ABLE TO BE USED IN THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750517 ↗
• MalfunctionAug 21, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION KIT WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEW PCA TUBING WAS OPENED AND PRIMED WITH MED. CONNECTION PORT WHERE TUBING CONNECTS TO IV HAD CRACK AND MED THEREFORE LEAKED AND DIDN'T REACH PATIENT. HAD TO WASTE MED IN TUBING AND GET NEW SET-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020960 ↗
• MalfunctionJan 18, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT BD ALARIS PCA ADMINISTRATION KIT OVER INFUSED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PRODUCT COMPLAINT MMS AND MDS. HAS PUMP IN BIOMED. ISSUE: INFUSION RATE HAPPENING QUICKER THAN EXPECTED HAD TO OPEN ANOTHER KIT. THE SECOND KIT DID NOT GIVE THEM ANY ISSUES. MAT REF: (B)(4) KIT PCA KIT MDS. RETAIN SAMPLE OF KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536684 ↗
• MalfunctionOct 12, 2023Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION KIT WAS INCOMPATIBLE WITH THE SYRINGE, CAUSING CRACKS IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS HAVING PROBLEMS WITH SKU 8881135609, IN PARTICULAR THEY ARE SEEING CRACKS IN THE BARREL OF THE SYRINGE DURING INFUSIONS WITH THE ALARIS PCA PUMPS. THEY USE SKU 10800175 (PLUNGER) AND ARE WONDERING IF THESE ARE NO LONGER COMPATIBLE DUE TO RECENT NEWS OF MONOJECT CHANGES.""

  Patient problems: Insufficient Information

  MAUDE report 17926643 ↗
• MalfunctionJun 26, 2023Leak/Splash; Material Perforation; Leak/Splash; Material Perforation

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV THERE WAS COMPONENT DAMAGE AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 10800175 BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT ADDITIONAL LEAKAGE HAPPENED ON (B)(6) 2023, (B)(6) 2023. CUSTOMER STAYED THAT THERE IS HOLES IN TUBING DESCRIBED AS MICRO-PUNCTURES. THERE WERE NO ADVERSE EVENTS/INJURIES. VERBATIM: ADDITIONAL INFO RECEIVED ON (B)(4). TUBING DEFECTIVE AND LEAKAGE ¿ DATE OF INCIDENT: (B)(6) 2023 WAS THERE ANY PATIENT INVOLVEMENT? IF YES, WHAT IS THE PATIENT OUTCOME? IS THERE ANY ADVERSE EVENT/SERIOUS INJURY? YES, THREE PATIENTS INVOLVED. ALL THREE PATIENTS ARE OUT OF ICU AND ON STEP-DOWN UNITS, STILL ADMITTED TO THE HOSPITAL. THERE WERE NO ADVERSE EVENTS/INJURIES. WAS THERE ANY EXPOSURE TOWARDS THE PATIENT OR HEALTHCARE WORKER? NO KNOWN EXPOSURE. HOW MANY OCCURRENCES OF THE DEFECTIVE ITEM? THREE SEPARATE OCCURRENCES. LEAKAGE ¿ (PAST TWO MONTHS). ARE YOU ABLE TO PROVIDE DATE OF INCIDENT FOR EVENT IN THE FORMAT OF DD-MM-YYYY? (B)(6) 2023. WAS THERE ANY NOTICEABLE CRACK OR HOLE THAT CAUSED LEAKAGE FOR THE INCIDENT WITHIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198857 ↗
• MalfunctionJun 26, 2023Leak/Splash; Material Perforation; Leak/Splash; Material Perforation

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV THERE WAS COMPONENT DAMAGE AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 10800175 BATCH#: UNKNOWN IT WAS REPORTED BY CUSTOMER THAT ADDITIONAL LEAKAGE HAPPENED ON (B)(6) 2023, (B)(6) 2023. CUSTOMER STAYED THAT THERE IS HOLES IN TUBING DESCRIBED AS MICRO-PUNCTURES. THERE WERE NO ADVERSE EVENTS/INJURIES. VERBATIM: ADDITIONAL INFO RECEIVED ON PR(B)(4) TUBING DEFECTIVE AND LEAKAGE ¿ DATE OF INCIDENT: (B)(6) 2023. 1. WAS THERE ANY PATIENT INVOLVEMENT? IF YES, WHAT IS THE PATIENT OUTCOME? IS THERE ANY ADVERSE EVENT/SERIOUS INJURY? A. YES, THREE PATIENTS INVOLVED. ALL THREE PATIENTS ARE OUT OF ICU AND ON STEP-DOWN UNITS, STILL ADMITTED TO THE HOSPITAL. THERE WERE NO ADVERSE EVENTS/INJURIES. 2. WAS THERE ANY EXPOSURE TOWARDS THE PATIENT OR HEALTHCARE WORKER? A. NO KNOWN EXPOSURE. 3. HOW MANY OCCURRENCES OF THE DEFECTIVE ITEM? A. THREE SEPARATE OCCURRENCES. LEAKAGE ¿ (PAST TWO MONTHS) ARE YOU ABLE TO PROVIDE DATE OF INCIDENT FOR EVENT IN THE FORMAT OF DD-MM-YYYY? A. (B)(6) 2023 2. WAS THERE ANY NOTICEABLE CRACK OR HOLE THAT CAUSED LEAKAGE F

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17198847 ↗
• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV LEAKAGE OCCURRED. THIS IS REPORT 4 OF 4. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WITNESSED POOLING PCA MEDICATION ON THE FLOOR OF SICU 401. UPON INSPECTION, MEDICATION WAS "SEEPING" OUT FROM PCA IV TUBING AND ONTO THE FLOOR ALONG THE ENTIRE LENGTH OF THE TUBING. NO EVIDENCE OF EXTERNAL TAMPERING WITH PCA IV TUBING, BUT RATHER DEFECTIVE OR IMPROPERLY MANUFACTURED TUBING AS EVIDENCED BY THE MICROSCOPIC HOLES THAT RUN ALONG THE FULL LENGTH OF THE TUBING. UNIT MANAGER NOTIFIED. CALL PLACED TO PHARMACY TO INQUIRE ABOUT OTHER INSTANCES OF DEFECTIVE TUBING, PHARMACY TECH HAD NOT HEARD ANYTHING AND ENCOURAGED RN TO CALL CENTRAL SUPPLY. RN PLACED CALL TO CENTRAL SUPPLY, AND SUPPLY EMPLOYEE WAS UNAWARE OF ANY DEFECTIVE TUBING. *OF NOTE: WITHIN THE PAST 2 MONTHS, THERE HAVE BEEN AT LEAST 2 OTHER INSTANCES ON SICU OF PCA IV TUBING NEEDING TO BE CHANGED DUE TO MEDICATION LEAKING ONTO THE FLOOR. THESE INSTANCES WERE UNDOCUMENTED AS THEY WERE THOUGHT TO BE COINCIDENCE, HOWEVER NOW SEEM TO BE EVIDENCE OF A LARGER SUPPLY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131279 ↗
• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV THERE WAS TUBING DAMAGE AND LEAKAGE OCCURRED. THIS IS REPORT 1 OF 4. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WITNESSED POOLING PCA MEDICATION ON THE FLOOR OF SICU 401. UPON INSPECTION, MEDICATION WAS "SEEPING" OUT FROM PCA IV TUBING AND ONTO THE FLOOR ALONG THE ENTIRE LENGTH OF THE TUBING. NO EVIDENCE OF EXTERNAL TAMPERING WITH PCA IV TUBING, BUT RATHER DEFECTIVE OR IMPROPERLY MANUFACTURED TUBING AS EVIDENCED BY THE MICROSCOPIC HOLES THAT RUN ALONG THE FULL LENGTH OF THE TUBING. UNIT MANAGER NOTIFIED. CALL PLACED TO PHARMACY TO INQUIRE ABOUT OTHER INSTANCES OF DEFECTIVE TUBING, PHARMACY TECH HAD NOT HEARD ANYTHING AND ENCOURAGED RN TO CALL CENTRAL SUPPLY. RN PLACED CALL TO CENTRAL SUPPLY, AND SUPPLY EMPLOYEE WAS UNAWARE OF ANY DEFECTIVE TUBING. OF NOTE: WITHIN THE PAST 2 MONTHS, THERE HAVE BEEN AT LEAST 2 OTHER INSTANCES ON SICU OF PCA IV TUBING NEEDING TO BE CHANGED DUE TO MEDICATION LEAKING ONTO THE FLOOR. THESE INSTANCES WERE UNDOCUMENTED AS THEY WERE THOUGHT TO BE COINCIDENCE, HOWEVER NOW SEEM TO BE EVIDENCE OF A LARGER SUPPLY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131277 ↗
• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED, WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV. LEAKAGE OCCURRED. THIS IS REPORT 3 OF 4. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WITNESSED POOLING PCA MEDICATION ON THE FLOOR OF SICU 401. UPON INSPECTION, MEDICATION WAS "SEEPING" OUT FROM PCA IV TUBING AND ONTO THE FLOOR ALONG THE ENTIRE LENGTH OF THE TUBING. NO EVIDENCE OF EXTERNAL TAMPERING WITH PCA IV TUBING, BUT RATHER DEFECTIVE OR IMPROPERLY MANUFACTURED TUBING AS EVIDENCED BY THE MICROSCOPIC HOLES THAT RUN ALONG THE FULL LENGTH OF THE TUBING. UNIT MANAGER NOTIFIED. CALL PLACED TO PHARMACY TO INQUIRE ABOUT OTHER INSTANCES OF DEFECTIVE TUBING. PHARMACY TECH HAD NOT HEARD ANYTHING AND ENCOURAGED RN TO CALL CENTRAL SUPPLY. RN PLACED CALL TO CENTRAL SUPPLY AND SUPPLY EMPLOYEE WAS UNAWARE OF ANY DEFECTIVE TUBING. *OF NOTE: WITHIN THE PAST 2 MONTHS, THERE HAVE BEEN AT LEAST 2 OTHER INSTANCES ON SICU OF PCA IV TUBING NEEDING TO BE CHANGED, DUE TO MEDICATION LEAKING ONTO THE FLOOR. THESE INSTANCES WERE UNDOCUMENTED, AS THEY WERE THOUGHT TO BE COINCIDENCE. HOWEVER, NOW SEEM TO BE EVIDENCE OF A LARGER SUPPLY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131273 ↗
• MalfunctionJun 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV LEAKAGE OCCURRED. THIS IS REPORT 2 OF 4. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN WITNESSED POOLING PCA MEDICATION ON THE FLOOR OF SICU 401. UPON INSPECTION, MEDICATION WAS "SEEPING" OUT FROM PCA IV TUBING AND ONTO THE FLOOR ALONG THE ENTIRE LENGTH OF THE TUBING. NO EVIDENCE OF EXTERNAL TAMPERING WITH PCA IV TUBING, BUT RATHER DEFECTIVE OR IMPROPERLY MANUFACTURED TUBING AS EVIDENCED BY THE MICROSCOPIC HOLES THAT RUN ALONG THE FULL LENGTH OF THE TUBING. UNIT MANAGER NOTIFIED. CALL PLACED TO PHARMACY TO INQUIRE ABOUT OTHER INSTANCES OF DEFECTIVE TUBING, PHARMACY TECH HAD NOT HEARD ANYTHING AND ENCOURAGED RN TO CALL CENTRAL SUPPLY. RN PLACED CALL TO CENTRAL SUPPLY, AND SUPPLY EMPLOYEE WAS UNAWARE OF ANY DEFECTIVE TUBING. *OF NOTE: WITHIN THE PAST 2 MONTHS, THERE HAVE BEEN AT LEAST 2 OTHER INSTANCES ON SICU OF PCA IV TUBING NEEDING TO BE CHANGED DUE TO MEDICATION LEAKING ONTO THE FLOOR. THESE INSTANCES WERE UNDOCUMENTED AS THEY WERE THOUGHT TO BE COINCIDENCE, HOWEVER NOW SEEM TO BE EVIDENCE OF A LARGER SUPPLY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131271 ↗
• MalfunctionJun 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ PCA KIT ASV MICROBORE CV LEAKAGE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE CNA WENT INTO THE PATIENT ROOM DUE TO A PATIENT CALL LIGHT ON, SHE VOLTED RN "NEED YOU IN 24. IV LINE BROKE." PCA TUBING CAME APART AT THE Y SITE ON THE HYDROMORPHONE SIDE. LACTATED RINGERS HAD BEEN FLOWING THROUGH THE DISCONNECTED SIDE ONTO THE PATIENT. BOTH FLUIDS PAUSED. PCA TUBING CHANGED AND PRIMED THROUGH THE PUMP. FLUIDS AND PCA RECONNECTED TO PATIENT". VERBATIM: DESCRIBE THE EVENT OR PROBLEM: (B)(6) 2023 AT 2014 WHEN THE CNA WENT INTO THE PATIENT ROOM DUE TO A PATIENT CALL LIGHT ON, SHE VOLTED RN "NEED YOU IN 24. IV LINE BROKE." PCA TUBING CAME APART AT THE Y SITE ON THE HYDROMORPHONE SIDE. LACTATED RINGERS HAD BEEN FLOWING THROUGH THE DISCONNECTED SIDE ONTO THE PATIENT. BOTH FLUIDS PAUSED. PCA TUBING CHANGED AND PRIMED THROUGH THE PUMP. FLUIDS AND PCA RECONNECTED TO PATIENT. PATIENT CHANGED INTO CLEAN GOWN AND NEW LINEN. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PCA-PAIN CONTROL . WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17121340 ↗
• MalfunctionOct 27, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA KIT ASV MICROBORE CV LEAKED AND WHEN CHANGING THE TUBE THERE WAS A NOTICEABLE CRACK AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING LEAKS AT Y-HUB (SEE PIC). USUALLY LEAKS AFTER THE PACU HOOKS UP TUBING AND THE PATIENT TRANSPORTS TO PSU. WHEN THE PSU NURSE CHANGES THE TUBING THERE IS A NOTICEABLE CRACK AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683155 ↗
• MalfunctionMar 24, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PCA ADMINISTRATION KIT CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: PATIENT HAD A PCA AND THE CONNECTION PORT BETWEEN THE PCA AND THE PRIMARY IVF CRACKED AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13876151 ↗
• MalfunctionMar 8, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS PCA ADMINISTRATION KIT CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "PATIENT HAD A PCA AND THE CONNECTION PORT BETWEEN THE PCA AND THE PRIMARY IVF CRACKED AND LEAKED. PER RN REPORT, THIS WAS THE 2ND PATIENT THAT SHE HAS KNOWN THIS TO HAPPEN TO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693561 ↗
• MalfunctionFeb 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHILE USING BD ALARIS¿ PCA KIT ASV MICROBORE CV FOREIGN MATTER WAS FOUND IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 10800175. BATCH/ LOT #: 21065588. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS DEBRIS FOUND ON THE TUBING WHILE REMOVING FROM THE PACKAGING. VERBATIM: A PCA TUBING SET THAT WAS FOUND TO HAVE SOME KIND OF CONTAMINATION IN THE TUBING BEFORE USE. EVENT DATE: (B)(6) 2022. EVENT SUMMARY: WENT TO SET UP A PCA ON THIS PATIENT AND WHEN THE TUBING WAS TAKEN OUT OF THE PACKAGE, DEBRIS WAS FOUND IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416504 ↗
• MalfunctionOct 27, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS¿ PCA ADMINISTRATION KIT SALINE PORT DISCONNECTED FROM THE TUBING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORMAL SALINE PORT DISCONNECTED ENTIRELY FROM TUBING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705293 ↗
• MalfunctionJul 2, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PCA KIT ASV MICROBORE CV TUBING LEAKED AFTER CONNECTING IT TO THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT CONTROLLED ANALGESIA (PCA) TUBING NOTED TO BE LEAKING ON THE SITE AFTER THE CONNECTION OF THE SYRINGE AND TUBING. PATIENT S/P MVA (STATUS POST MOTOR VEHICLE ACCIDENT) RECEIVING DILAUDID PCA, FOR PAIN MANAGEMENT TO TREAT THE PAIN FROM THE LEFT FRACTURED FEMUR AND LEFT ARM, NOTED LIQUID DRIPPING FROM THE PCA TUBING. SET UP CHANGED TO NEW SETTINGS. NURSING PROVIDED DEFECTIVE TUBING. REMOVED TUBING FROM OPERATION AND PRIMED NEW SET FOR PATIENT USE APPROPRIATELY. THIS PRODUCT WAS REMOVED/DISPOSED. THERE WAS NO HARM DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111917 ↗
• MalfunctionJun 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PCA KIT Y CONN CHECK VLV 90 INCH WAS DEFORMED/DAMAGED/CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 10800175. BATCH NO.: UNKNOWN. PT STATED THAT HER PCA TUBING WAS LEAKING. RN ASSESSED AND NOTED THAT LEAK WAS NOT COMING FROM SYRINGE OR CONNECTIONS. PCA STOPPED AND TUBING REMOVED. AFTER INSPECTION OF THE TUBING A SMALL CRACK WAS NOTED IN THE LINE. NEW TUBING FOR BOTH PCA AND HYDRATION WERE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089761 ↗
• MalfunctionJun 15, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PCA KIT ASV MICROBORE CV LEAKED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THEY HAD TWO DEFECTIVE SETS THAT LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12006063 ↗
• MalfunctionMar 23, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MEDICATION LEAKED FROM THE DISTAL PORT OF THE PCA KIT ASV MICROBORE CV TUBING DUE TO A LOOSE IV SET CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS NO HARM TO THE PATIENT, BUT THE MEDICATIONS WAS LEAKING FROM THE DISTAL PORT OF THE TUBING. THE PATIENT WAS FOUND IN A PUDDLE OF IV FLUIDS AND THEY WERE NOT ABLE TO MAKE A TIGHT CONNECTION. THE MEDICATION WAS WASTED AND THE NURSE STARTED A NEW SET UP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11548417 ↗