BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK TIP SYRINGE

    MDR report key: 8927004 · Received August 23, 2019

    Report

    Report Number
    1911916-2019-00852
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 9, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6011961. MEDICAL DEVICE EXPIRATION DATE: 2021-01-31. DEVICE MANUFACTURE DATE: 2016-01-11. MEDICAL DEVICE LOT #: 9120506. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-30. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: FOUR (4) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) PHOTO SHOWS TWO (2) BLISTER PACKS. ONE (1) OF THE BLISTER PACKS SHOWS A LOT NUMBER OF 6011961 AND THE OTHER BLISTER PACK SHOWS A LOT NUMBER OF 9120506. THE SECOND (2ND) PHOTO SHOWS TWO (2) SYRINGES IN BLISTER PACKS. THE SYRINGE ON THE LEFT HAS DUAL SCALES AND THE SYRINGE ON THE RIGHT HAS ONLY ONE (1) SCALE. THE THIRD (3RD) PHOTO SHOWS THE SAME TWO (2) SYRINGES IN THE BLISTER PACKS ALSO SHOWING THAT THE SYRINGE ON THE LEFT HAS DUAL SCALES AND THE SYRINGE ON THE RIGHT HAS ONLY ONE (1) SCALE. THE FOURTH (4TH) PHOTO SHOWS THE TOP WEB OF THE TWO (2) BLISTER PACKS SHOWING THE PRODUCT INFORMATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES (6011961, 9120506) ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT ABLE TO BE PERFORMED ON THE BATCH (UNKNOWN) ASSOCIATED WITH THIS INVESTIGATION AS THE BATCH NUMBER WAS UNKNOWN. IN OCTOBER OF 2015 BD NOTIFIED CUSTOMERS THAT BD WOULD BE HARMONIZING SYRINGE BARREL SCALE MARKINGS BY REMOVING THE DUAL SCALE AND UTILIZING ONLY A MILLILITERS SCALE. AS BATCH 6011961 WAS PRODUCED IN JANUARY OF 2016 IT WAS PRODUCED BEFORE THIS CHANGE WAS IMPLEMENTED. BATCH 9120506 WAS PRODUCED IN APRIL OF 2019 AFTER THIS CHANGE WAS IMPLEMENTED. BASED ON THE INVESTIGATION CONCLUSION BD ACKNOWLEDGES THAT THE SYRINGES IN THE PHOTOS PROVIDED HAVE DIFFERENT SCALE MARKINGS AS ONE (1) SYRINGE HAS A DUAL SCALE AND ONE (1) SYRINGE ONLY HAS A MILLILITERS SCALE. HOWEVER, AS BOTH OF THESE BATCHES WERE PRODUCED CORRECTLY ACCORDING TO THE POLICIES AND PROCEDURES AT THE TIME OF PRODUCTION NO CORRECTIVE OR PREVENTATIVE ACTION WILL BE TAKEN IN THE SCOPE OF THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 30 ML BD LUER-LOK¿ TIP SYRINGE HAD SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 302832, BATCH NO.: 9120506, 6011961, UNKNOWN (REPORTED 5236991). IT WAS REPORTED DOUBLE SCALE AND SINGLE SCALES. PER EMAIL: WE RECEIVED SOME SYRINGE 30CC LOTS WITH ¿DOUBLE SCALE¿ AND SOME WITH ¿SINGLE SCALES¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722091 30 ML BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other