BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIC PACK¿ / BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE

    MDR report key: 7434935 · Received April 16, 2018

    Report

    Report Number
    1920898-2018-00214
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 1, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO INVESTIGATIONS WERE CARRIED OUT. FIRST INVESTIGATION SUMMARY: CUSTOMER RETURNED 3/10CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6347540. CUSTOMER STATES THAT THE SCALE WAS BLURRED. BOTH RETURNED SYRINGES WERE EXAMINED UNDER THE MICROSCOPE AND BOTH EXHIBITED SCRATCHES IN THE BARREL AROUND THE 1 UNIT MARKING. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 13APR2018 FOR FURTHER REVIEW. SECOND INVESTIGATION SUMMARY: ON 17APR2018, HOLDREGE RECEIVED TWO 0.3ML, 8MM, 30G SYRINGES IN AN OPENED POLYBAG FROM BATCH # 6347540. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. WHILE THE PARTIAL SCRATCH THROUGH THE 1U (1 UNIT) SCALE LINE WAS NOTED, AS THE SCALE MARKING IS STILL VISIBLE, THIS WOULD NOT REPRESENT A DEFECT, HAD IT BEEN NOTED DURING PRODUCTION WITH THE MANUFACTURING PLANT. THERE ARE NUMEROUS REASONS AND WAYS THAT A SYRINGE MAY BECOME SCRATCHED IN THIS MANNER, HOWEVER, AS NOTED WITHIN THESE SAMPLES, THIS REPRESENTS AN ACCEPTABLE VARIABLE PER MANUFACTURING SPECIFICATIONS AND WOULD NOT BE REJECTED. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 6347540 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTIVE ACTIONS ASSOCIATED WITH THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #6347540. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200678401, 200678402] NOTED FOR HIGH ZERO LINES. THERE WAS ONE (1) NOTIFICATION [200677967] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 6347540. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SCRATCHED BARREL) BASED ON THE ABOVE, NO NEW CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE A BD PLASTIC PACK¿ / BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE WAS FOUND WITH VOLUMETRIC INACCURACY AS ¿THE SCALE WAS BLURRED.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278024 BD PLASTIC PACK¿ / BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 6347540C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other