BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD¿ BULK SLIP TIP SYRINGE

    MDR report key: 7310373 · Received March 2, 2018

    Report

    Report Number
    1911916-2018-00071
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 9, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 7262994. MEDICAL DEVICE EXPIRATION DATE: 08/31/2022. DEVICE MANUFACTURE DATE: 09/19/2017. INVESTIGATION SUMMARY: A PHOTO SAMPLE WAS AVAILABLE FOR EVALUATION. BD TRANSITIONED FROM THE OUNCE/ML DUAL GRADUATION SCALE TO A SINGLE ML GRADUATION SCALE IN (B)(6) 2016 FOR 30 ML PRODUCT. BATCH 6033876 WAS MANUFACTURED IN (B)(6) 2016, 7 MONTHS BEFORE THE NEW SCALES WERE IMPLEMENTED. AT THAT TIME, THE EQUIPMENT REQUIRED TO PRINT THE OUNCELESS SCALE HAD NOT YET BEEN FABRICATED AND IT IS NOT POSSIBLE THAT A MIX OCCURRED AT THAT TIME. BATCH 7262994 WAS MANUFACTURED IN (B)(6) 2017, 13 MONTHS AFTER THE IMPLEMENTATION OF THE SINGLE ML SCALE. AT THAT TIME, THE EQUIPMENT TO PRINT THE OUNCE/ML DUAL SCALE WAS NOT AVAILABLE TO THE MANUFACTURING ASSOCIATES AND COULD NOT BE USED. THE TWO BATCHES WERE MANUFACTURED 20 MONTHS APART AND IT IS NOT POSSIBLE THAT THEY WERE MIXED TOGETHER IN THE MANUFACTURING PROCESS. THE TWO BATCHES WERE MANUFACTURED 20 MONTHS APART AND IT IS NOT POSSIBLE THAT THEY WERE MIXED TOGETHER IN THE MANUFACTURING PROCESS. IT IS HIGHLY UNLIKELY THAT SINGLE AND DUAL SCALES WERE MIXED WITHIN THE SAME BATCH AS THE TWO BATCHES LISTED WERE MANUFACTURED WELL OVER 6 MONTHS FROM WHEN THE TRANSITION FROM THE DUAL TO SINGLE SCALE OCCURRED. INVESTIGATION CONCLUSION: NO ISSUES WERE DETECTED IN THE MANUFACTURING PROCESS AND THE ROOT CAUSE IS NOT SUSPECTED TO HAVE OCCURRED DUE TO BD. NO FURTHER CORRECTIVE ACTION IS REQUIRED. IT IS POSSIBLE THAT THE BATCHES WERE INADVERTENTLY MIXED UPON RECEIPT BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOXES OF 30 ML BD¿ BULK SLIP TIP SYRINGE TIPS WERE FOUND EITHER WITH THE WRONG SYRINGE OR MIXED WITH BOTH THE ¿NEW METRIC SCALE¿ AND THE ¿OLD ORIGINAL SCALE¿ MARKINGS. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155031 30 ML BD¿ BULK SLIP TIP SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 7262994

    Patients

    Seq Age Sex Outcome Treatment
    1 Other