BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAB®

    MDR report key: 12810914 · Received November 15, 2021

    Report

    Report Number
    2021236-2021-00012
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    November 2, 2021
    Report Date
    May 27, 2022
    Manufacturer
    B. BRAUN MEDICAL INC
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) EMPTY PAB UNIT WAS RECEIVED FROM BATCH J1E651 FOR EVALUATION. A BLACK PARTICULATE MATTER WAS OBSERVED INSIDE THE UNIT. A SINGLE PUNCTURE WAS OBSERVED IN THE UNDERSIDE OF THE STOPPER. THERE WAS NO VISIBLE EVIDENCE OF STOPPER MATERIAL MISSING (CORING) DUE TO NEEDLE INSERTION AT THE ENTRY OR EXIT POINT OF THE STOPPER. THE PARTICLE INSIDE THE EMPTY PAB BAG WAS IDENTIFIED AS BUTYL RUBBER WHICH IS THE MATERIAL IN RUBBER STOPPERS. SINCE THE MATERIAL THE PAB STOPPER IS THE MOST COMMON MATERIAL SOLD IN THE US FOR DRUG VIALS, IT IS POSSIBLE THE PM PARTICLE CAME FROM ANOTHER SOURCE OF CORING (STOPPER) THAT WAS INJECTED INTO THE EMPTY PAB BAG THROUGH THE LUMEN OF THE NEEDLE WHEN MEDICATION WAS ADDED. INVESTIGATION SHOWS THE SOURCE OF THE CORE IS NOT THE PAB CONTAINER (STOPPER) RETURNED. TYPICALLY, THERE WOULD BE EVIDENCE SUCH AS MISSING MATERIAL OR FRAGMENT IN THE TOP OR BOTTOM SIDE OF THE STOPPER IF THE CORE WERE FROM THE RETURNED SAMPLE. A REVIEW OF OUR DISCREPANCY MANAGEMENT SYSTEM DATABASE FOUND NO RELATED OR SIMILAR DISCREPANCIES DURING THE PRODUCTION OF THE BATCH. VISUAL INSPECTION ON TWENTY (20) RETAINED UNITS REVEALED THAT NO PARTICULATE MATTER WAS OBSERVED IN ANY OF THE RETAINED UNITS.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). 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 · 0

    AS REPORTED BY THE USER FACILITY: AFTER COMPOUNDING FENTANYL INTO THE PAB BAG A DARK COLORED PARTICLE WAS FOUND IN THE SOLUTION. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715453 PAB® CONTAINER, IV KPE B. BRAUN MEDICAL INC S5904-52 J1E651 04046964187698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown