BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAB®

    MDR report key: 12157925 · Received July 13, 2021

    Report

    Report Number
    2021236-2021-00011
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 17, 2021
    Product Code
    KPE
    UDI-DI
    04046964187698
    PMA / PMN Number
    K840388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4), EVENT 11. TWO (2) EMPTY PAB CONTAINERS FROM BATCH J1B720 WERE RECEIVED FOR EVALUATION. BOTH UNITS HAD MEDICAL LABELS AND A RED PLASTIC COVER THAT ENCAPSULATES THE MED PORT. THE SET PORT OF BOTH UNITS HAD ALSO BEEN ACCESSED. THREE (3) GLASS DRUG VIALS WERE ALSO RETURNED WITH THE UNITS. ONE (1) OF THE GLASS DRUG VIALS WAS BROKEN. THE STOPPER OF THE DRUG VIALS HAD BEEN ACCESSED. GRAY COLORED PARTICULATE MATTER WAS OBSERVED IN BOTH EMPTY PAB CONTAINERS. THE PARTICLES MATCH THE RUBBER STOPPER FROM THE IV BAG. THE PARTICLES DID NOT MATCH THE RUBBER STOPPER OF THE DRUG VIAL. THE PUNCTURES IN THE STOPPERS APPEAR TO HAVE BEEN MADE BY A DEVICE LARGER THAN A 19G NEEDLE. THEREFORE THIS APPEARS TO BE USER ERROR BY NOT FOLLOWING THE DIRECTIONS FOR USE. AS THE PARTICLES WERE NOT FOUND PRIOR TO ACCESS, IT IS LIKELY THAT THE OBSERVED PARTICLES CAME OFF WHEN THE STOPPER WAS ACCESSED. STOPPER CORING COULD OCCUR IF AN UNSUITABLE DEVICE IS USED TO ACCESS THE MED PORT. MICROSCOPIC EVALUATION ON THE PUNCTURE ON THE STOPPER MADE BY THE CUSTOMER SUGGESTS THAT THE MED PORT WAS NOT ACCESSED BY A 19G NEEDLE. PER THE PAB MIXING CONTAINER DIRECTIONS FOR USE, TO ADD MEDICATION, A SYRINGE WITH 18G OR SMALLER NEEDLE SHOULD BE USED. BASED ON THE ABOVE INFORMATION, THE LIKELY CAUSE OF THE DEFECT IS USER ERROR. A 19G BD PRECISION GLIDE NEEDLE WAS USED TO CREATE A PUNCTURE ON STOPPER NUMBER 2 TO COMPARE THE 19G NUMBER WITH THE PUNCTURE CREATED BY THE CUSTOMER. THE PUNCTURE CREATED BY THE CUSTOMER WAS LARGER AND WAS NOT CLEAN. VISUAL INSPECTION ON TWENTY (20) RETAINED UNITS REVEALED THAT NO PARTICULATE MATTER WAS OBSERVED IN ANY OF THE RETAINED UNITS. THE BATCH RECORD WAS REVIEWED AND THE BATCH MET AND PASSED ALL RELEASE CRITERIA AND TESTS. A REVIEW OF OUR DISCREPANCY MANAGEMENT SYSTEM DATABASE FOUND NO RELATED OR SIMILAR DISCREPANCIES DURING THE PRODUCTION OF THE BATCH. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4), EVENT 9. THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT 9: DURING THE IN-PROCESS VISUAL INSPECTION FENTANYL DRIP BAGS WERE FOUND TO HAVE A DARK COLORED FLOATING PARTICLE INSIDE THE COMPOUNDED BAG. DRUG PRODUCT HAD BEEN ADDED TO THE BAG. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060044 PAB® CONTAINER, IV KPE S5904-52 J1B720 04046964187698

    Patients

    Seq Age Sex Outcome Treatment
    1