BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE 0.3ML INSULIN SYRINGE

    MDR report key: 12139040 · Received July 8, 2021

    Report

    Report Number
    1920898-2021-00730
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    March 26, 2021
    Report Date
    August 25, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/24/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (12) LOOSE 3/10CC, 8MM SYRINGES ALONG WITH (1) LOOSE HUB-NEEDLE/SHIELD ASSEMBLY. CUSTOMER STATES THAT THE PLUNGER DOES NOT RUN AT ALL. ALL RETURNED SYRINGES WERE TESTED AND NO HUB SEPARATION WAS OBSERVED. THE LOOSE HUB ASSEMBLY WAS RETURNED WITHOUT THE BARREL OF THE SYRINGE. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CAPA#(B)(4) WAS INITIATED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MICRO-FINE¿ 0.3ML INSULIN SYRINGE THERE WERE 6 NEEDLE HUBS THAT SEPARATED FROM THE DEVICE, AND 21 PLUNGER RODS THAT WERE DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: EITHER THE PLUNGER DOES NOT RUN AT ALL OR THE ENTIRE NEEDLE TEARS OFF WHEN THE CAP IS REMOVED. AFTER CONSULTING THE CUSTOMER OVER THE PHONE, AROUND 6 NEEDLES AND 21 PLUNGERS FROM A PACK OF 100 HAVE BEEN AFFECTED SO FAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MICRO-FINE¿ 0.3ML INSULIN SYRINGE THERE WERE 6 NEEDLE HUBS THAT SEPARATED FROM THE DEVICE, AND 21 PLUNGER RODS THAT WERE DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: EITHER THE PLUNGER DOES NOT RUN AT ALL OR THE ENTIRE NEEDLE TEARS OFF WHEN THE CAP IS REMOVED. AFTER CONSULTING THE CUSTOMER OVER THE PHONE, AROUND 6 NEEDLES AND 21 PLUNGERS FROM A PACK OF 100 HAVE BEEN AFFECTED SO FAR.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FAX #: (B)(6). INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD MICRO-FINE¿ 0.3ML INSULIN SYRINGE THERE WERE 6 NEEDLE HUBS THAT SEPARATED FROM THE DEVICE, AND 21 PLUNGER RODS THAT WERE DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: EITHER THE PLUNGER DOES NOT RUN AT ALL OR THE ENTIRE NEEDLE TEARS OFF WHEN THE CAP IS REMOVED. AFTER CONSULTING THE CUSTOMER OVER THE PHONE, AROUND 6 NEEDLES AND 21 PLUNGERS FROM A PACK OF 100 HAVE BEEN AFFECTED SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034605 BD MICRO-FINE 0.3ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0090628

    Patients

    Seq Age Sex Outcome Treatment
    1