BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUNGER ROD

    MDR report key: 16019478 · Received December 20, 2022

    Report

    Report Number
    2243072-2022-02202
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 23, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A PURPLE PLUNGER ROD (PR) INTO A BAG OF BLUE PLUNGER RODS DETECTED DURING THE PLUNGER ROD ASSEMBLY PROCESS. TWO PICTURE EVIDENCES WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS ON (B)(6) 2022. ON THE PROVIDED PICTURE, ONE PURPLE PLUNGER ROD IS VISIBLE INSIDE A BLISTER ASIDE ANOTHER BLISTER CONTAINING ONE PR FROM THE INVOLVED BLUE BATCH # 2142808. IN BOTH BD AND CUSTOMER PRODUCT DESCRIPTIONS, IT IS CLEARLY STATED THE PARTS SHOULD BE BLUE. THE INVOLVED BATCH 2142808 IS A PARENT BATCH MANUFACTURED AT BDM-PS APPROVED SUPPLIER. 1,080,800 UNITS CORRESPONDING TO 180 CASES OF 6,000 UNITS EACH WERE MANUFACTURED PLUS 800 CUSTOMER SAMPLES. THERE IS NO UNIT IN STORAGE. ALL UNITS AND CUSTOMER SAMPLES WERE SHIPPED TO THE CUSTOMER. BDM-PS PERFORMED A REVIEW OF THE RELEASE DOCUMENTATION AND DID NOT IDENTIFY ANY NON-CONFORMANCE. THE BATCH INVOLVED IN THIS COMPLAINT MET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WAS MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON THE PROVIDED PICTURE EVIDENCES, BDM-PS CAN CONFIRM THE CONDITION REPORTED BY THE CUSTOMER. AS IMMEDIATE ACTION, AN OFFICIAL QUALITY COMPLAINT WAS RAISED TO THE SUPPLIER. THE INVOLVED BATCH 2142808 STARTED ON (B)(6) 2021 AND ENDED ON (B)(6) 2021 ON MOLD 1670 AND MACHINE A14. THE PURPLE PR WAS IDENTIFIED AS BD REFERENCE (B)(4). ON THE PRESS A14, THIS REFERENCE WAS PRODUCED FROM (B)(4) 2021, I.E. 3 MONTHS BEFORE THE INVOLVED BATCH 2142808 AND ALSO IN (B)(4) 2021 I.E. 3 MONTHS AFTER THE INVOLVED BATCH 2142808. THIS REFERENCE WAS NEVER PRODUCED DURING THE MANUFACTURING OF THE INVOLVED BATCH 2142808. THE HYPOTHESIS OF A PR STUCK IN THE MACHINE A14 FOR 3 MONTHS SEEMS VERY UNLIKELY, ESPECIALLY SINCE DURING THESE 3 MONTHS 2 BATCHES WERE PRODUCED. UNCONFIRMED: THE REPORTED CONDITION IS NOT DETERMINED TO BE CAUSED BY BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUNGER ROD HAS MIX OF PRODUCT TYPES IN THE PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PLUNGER ROD ASSEMBLY PROCESS ON (B)6) 2022, A DIFFERENT COLOR PLUNGER ROD (PURPLE) WAS FOUND AT THE ASSEMBLY LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457344 BD ULTRASAFE PLUNGER ROD PISTON SYRINGE FMF BECTON DICKINSON 2142808

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown