BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE

    MDR report key: 8471314 · Received April 1, 2019

    Report

    Report Number
    1920898-2019-00299
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 14, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 0.5ML, 6MM, 31G BD INSULIN SYRINGE. CONSUMER REPORTED THAT A PIECE OF THE SYRINGE BARREL IS MISSING. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN BARREL, THUS CONFIRMING THE ALLEGED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8141517. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200761061, 200761699] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200761724] NOTED FOR DAMAGED TIPS. PROBABLE ROOT CAUSE WAS NOTED TO BE THE BARREL LIKELY BEING BROKEN IN THE PREP DIAL PRIOR TO ASSEMBLY, WHICH ACCOUNTS FOR THE LACK OF DAMAGE TO THE NEEDLE ASSEMBLY.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8141517. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR DAMAGED TIPS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE HAD A HOLE IN THE BARREL. THE FOLLOWING WAS REPORTED, "MATERIAL NO. 324911 BATCH NO. 8141517. IT WAS REPORTED THAT THERE WAS A HOLE IN THE BARREL OF THE SYRINGE. VERBATIM: CONSUMER REPORTED THAT A PIECE OF THE SYRINGE BARREL IS MISSING, SYRINGE WAS IN A SEALED POLY BAG. CONSUMER NOTICED THE HOLE AT THE TOP OF BARREL WHEN SHE WAS ABOUT TO DRAW THE INSULIN. PROBLEM OCCURRED ON 03-14-19. LOT # 8141517, PRODUCT # 324911, EXP 06-30-2023. SENDING MAIL KIT AND PRODUCT VOUCHER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE HAD A HOLE IN THE BARREL. THE FOLLOWING WAS REPORTED, "MATERIAL NO. 324911 BATCH NO. 8141517 IT WAS REPORTED THAT THERE WAS A HOLE IN THE BARREL OF THE SYRINGE. VERBATIM: CONSUMER REPORTED THAT A PIECE OF THE SYRINGE BARREL IS MISSING, SYRINGE WAS IN A SEALED POLY BAG. CONSUMER NOTICED THE HOLE AT THE TOP OF BARREL WHEN SHE WAS ABOUT TO DRAW THE INSULIN. PROBLEM OCCURRED ON 03-14-19. LOT # 8141517, PRODUCT # 324911, EXP 06-30-2023. SENDING MAIL KIT AND PRODUCT VOUCHER."

    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 A BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE HAD A HOLE IN THE BARREL. THE FOLLOWING WAS REPORTED, "MATERIAL NO. 324911, BATCH NO. 8141517. IT WAS REPORTED THAT THERE WAS A HOLE IN THE BARREL OF THE SYRINGE. VERBATIM: CONSUMER REPORTED THAT A PIECE OF THE SYRINGE BARREL IS MISSING, SYRINGE WAS IN A SEALED POLY BAG. CONSUMER NOTICED THE HOLE AT THE TOP OF BARREL WHEN SHE WAS ABOUT TO DRAW THE INSULIN. PROBLEM OCCURRED ON (B)(6) 2019. LOT # 8141517, PRODUCT # 324911, EXP 06-30-2023. SENDING MAIL KIT AND PRODUCT VOUCHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263341 BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8141517 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other