BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML REG PR SALINE FILL SPKG

    MDR report key: 18171274 · Received November 20, 2023

    Report

    Report Number
    9616657-2023-00051
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 19, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    UDI-DI
    30382903065531
    PMA / PMN Number
    K042061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306553 AND LOT NUMBERS 3110715 AND 3096557. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESSES THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE AND TWO (2) PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. BOTH OF THE PHYSICAL SAMPLES RECEIVED WERE STILL WITHIN THEIR ORIGINAL PACKAGING. THE BARCODES ON BOTH SAMPLES WERE SCANNED USING THE MICROSCAN LVS BARCODE VERIFIER. THE RESULTS SHOWED THAT THE EXPIRY DATE STRING WAS IN THE INCORRECT FORMATION, READING DDMMYY WHEN IT SHOULD READ YYMMDD. THE INCORRECT DATE FORMAT RESULTED FROM AN ERROR IN THE PRINT RECIPE IN THE BELLMARK SYSTEM. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO RECTIFY THIS ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 22-NOV-2023. THIS IS THE BARCODE SCAN RESULTS. ]D2010038290306553017310326103110715. THE PORTION IN BOLD AND UNDERLINE IS THE DATE STAMP. WE FEEL THIS DATE IS FORMATTED YYMMDD WHILE WE¿RE EXPECTING IT TO BE DDMMYY. THUS, THE EXPIRATION DATE IS PARSING INCORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 10ML REG PR SALINE FILL SPKG BARCODE SCANNED EXPIRATION DATE WAS BEYOND THE POUCH LABELED EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE FOUND THROUGH THE COURSE OF DISPENSING THAT AT LEAST 2 LOTS OF THIS ITEM HAVE AN EXPIRATION DATE IN THE BARCODE THAT IS DIFFERENT FROM THAT PRINTED ON THE PRODUCT. THE PRINTED EXPIRATION DATE IS 3/31/2026 BUT THE BARCODE RETURNS 3/26/2031. THE BARCODE IN THE SCREENSHOT IS: ]D2010038290306553017310326103110715. ACCORDING TO THE DCSCA SUPPORT GROUP THE PORTION IN BOLD IS THE EXPIRATION DATE AND IT SHOULD READ 260331. PLEASE LET US KNOW IF WE HAVE TO QUARANTINE SUPPLY. I THINK IT¿S QUITE LIKELY THAT OUR ENTIRE ON HAND INVENTORY IS AFFECTED. WE ONLY STARTED SCANNING 2D BARCODES LAST WEEK SO WE CAN¿T SAY WHEN THIS STARTED BUT IT MAY HAVE BEEN GOING ON FOR SOME TIME. ADDITIONAL INFORMATION RECEIVED ON 02-NOV-2023 ¿ ANY OTHER LOT'S# IDENTIFIED WITH THE SAME ISSUE? NOT YET. THESE TWO LOTS ARE THE ONLY ONES WE HAVE IN STOCK. ¿ WHAT IS THE DATE WHEN THE EVENT WAS DISCOVERED? (B)(6) 2023

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021484 BD SYRINGE 10ML REG PR SALINE FILL SPKG SALINE VASCULAR ACCESS FLUSH NGT BECTON, DICKINSON AND CO. 3096557 30382903065531

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown