BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ U-40 1ML, 29G X 12.7MM INSULIN SYRINGE

    MDR report key: 6908133 · Received October 2, 2017

    Report

    Report Number
    1920898-2017-00211
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    September 7, 2017
    Report Date
    December 8, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07NOV2017, HOLDREGE RECEIVED ONE (1) RELION SYRINGE WITH AN ADDITIONAL DAMAGED PLUNGER ROD/CAP, BOTH IN AN OPENED PLOYBAG FROM BATCH# 7023645. ALL SAMPLES WERE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, ADDITIONAL INFORMATION REGARDING THE DAMAGED PLUNGER ROD/CAP NOTES THAT THIS TYPE OF DAMAGE IS LIKELY DUE TO A JAW JAM ON THE FF&S (FORM FILL AND SEAL), WHERE THE SYRINGES ARE PACKAGED AND SEALED WITHIN THE POLYBAG. WHEN A JAW JAM OCCURS, SYRINGES AND/OR COMPONENTS CAN BE DAMAGED, BUT STILL MAKE IT INTO THE POLYBAG IN THE PROCESS. NO ADDITIONAL INFORMATION REGARDING THE MISSING CANNULA AT THIS TIME.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED SYRINGES IN AN OPEN POLY BAG FROM LOT # 7023645. CUSTOMER STATES THAT THE NEEDLE IS MISSING AND THE NEEDLE STUCK IN THE VIAL. ONE SAMPLE WAS RETURNED WITH ONLY THE PLUNGER ROD AND PLUNGER CAP. THE PLUNGER CAP WAS OBSERVED TO BE CRUSHED AND BENDING THE PLUNGER ROD. THE REMAINING SYRINGE WAS EXAMINED AND EXHIBITED A DETACHED CANNULA. THIS SAMPLE WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED ADHESIVE RUNOFF ONTO THE HUB AND A DAMAGED HUB. SAMPLES WILL BE FORWARDED TO MANUFACTURING ((B)(4)) ON 03NOV2017 FOR FURTHER REVIEW. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THE ADHESIVE RUNOFF ISSUE. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7023645. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE (ADHESIVE RUNOFF AND CRUSHED CAP). PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE REMOVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE. POSSIBLE ROOT CAUSE FOR CRUSHED PLUNGER CAP: THE SYRINGE WAS CAUGHT IN THE SEALING BARS OF THE PACKAGING MACHINE, CRUSHING THE CAP AND BREAKING THE PLUNGER. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS ADHESIVE RUN OVER/SHIELD DIFFICULT TO REMOVE AND THEIR ASSOCIATED ROOT CAUSE(S).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE NEEDLE ON THE BD MICRO-FINE" U-40 1ML, 29G X 12.7MM INSULIN SYRINGE REMAINED IN VIAL DURING MEDICATION DRAW. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687313 BD MICRO-FINE¿ U-40 1ML, 29G X 12.7MM INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other