BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGE W/ BD ULTRA-FINE 6MM NEEDLE

    MDR report key: 9175883 · Received October 10, 2019

    Report

    Report Number
    1920898-2019-01123
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 25, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (3) 1/2CC, 6MM, 31G SYRINGES IN OPEN POLY BAGS FROM LOT # 9063699. CUSTOMER STATES THAT THE NEEDLE AND HUB WAS DETACHED FROM THE SYRINGE WHEN REMOVING THE NEEDLE SHIELD. TWO OUT OF 3 SYRINGES WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063699. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 22OCT2019, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE, FROM MATERIAL 324911, BATCH 9063699. VISUAL INSPECTION OF THE PICTURE, FOUND TWO SYRINGES WITH THE NEEDLE ASSEMBLIES DETACHED FROM THE BARRELS. NO DAMAGE WAS OBSERVED ON THE HUBS OR BARREL TIPS. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.5ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIMEFRAME OF THIS BATCH THAT PERTAIN TO THIS DEFECT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. THIS BATCH WAS PRODUCED PRIOR TO THE COMPLETION OF ACR19-04-007 AND SCR19-04-003 WHICH ADDRESSED THE ISSUE OF NEEDLE HUB SEPARATION BY REPLACING THE SENSOR EYES WITH CAMERAS FOR MORE ACCURATE MEASUREMENT OF RAISED NEEDLE ASSEMBLIES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE AND HUB WERE DETACHED FROM BD VEO¿ INSULIN SYRINGE W/ BD ULTRA-FINE 6MM NEEDLE DURING USE. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 324911 BATCH NO.: 9063699. IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE AND HUB WERE DETACHED FROM THE SYRINGE WHEN REMOVING THE NEEDLE SHIELD. VERBATIM: ISSUE: CONSUMER REPORTED NEEDLE AND HUB WAS DETACHED FROM THE SYRINGE WHEN REMOVING THE NEEDLE SHIELD COUPLE OF DAYS AGO. 1 SYRINGE HALFWAY DETACHED FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE AND HUB WERE DETACHED FROM BD VEO¿ INSULIN SYRINGE W/ BD ULTRA-FINE 6MM NEEDLE DURING USE. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 324911, BATCH NO.: 9063699. IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE AND HUB WERE DETACHED FROM THE SYRINGE WHEN REMOVING THE NEEDLE SHIELD. VERBATIM: ISSUE: CONSUMER REPORTED NEEDLE AND HUB WAS DETACHED FROM THE SYRINGE WHEN REMOVING THE NEEDLE SHIELD COUPLE OF DAYS AGO. 1 SYRINGE HALFWAY DETACHED FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968468 BD VEO INSULIN SYRINGE W/ BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9063699 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other