BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9161430 · Received October 7, 2019

    Report

    Report Number
    1920898-2019-01092
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 31, 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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8113606. CUSTOMER STATES THAT THE SYRINGE IS MISSING THE CAP, SHIELD, AND FLANGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A MISSING SHIELD AND THE BARREL BROKEN OFF AT THE FLANGE WITHOUT THE PLUNGER CAP. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113606. 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 (MISSING SHIELD AND PLUNGER CAP AND BROKEN BARREL). AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 22OCT2019, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE, FROM MATERIAL 324911, BATCH 8113606. VISUAL INSPECTION OF THE PICTURE FOUND THE SHIELD MISSING, THE HUB AND CAP MISSING, THE BARREL BROKEN OFF BELOW THE FLANGE, AND THE THUMB PRESS OF THE PLUNGER BROKEN OFF. HALF OF THE BARREL FLANGE WAS INCLUDED IN THE PICTURE, SEPARATED FROM THE BARREL. 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 QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. ROOT CAUSE CANNOT BE DETERMINED. 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 STERILE BREACH OCCURRED WITH A BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FROM PHONE CALL ON (B)(6) 2019 14:08:13: THIS ADULT CONSUMER'S PARENT CALLED BACK WITH PRODUCT INFORMATION. CONSUMER IS VISION IMPAIRED. ITEM # 324911 WITH LOT # 8113606 FOUND ON (B)(6) 2019 1 SYRINGE WITHOUT A PLUNGER CAP OR FLANGE ON THE SYRINGE. ALSO THE NEEDLE SHIELD MISSING AND DID NOT FIND THE PIECES WITHIN THE POLY BAG. THEY CAN SEND THIS SYRINGE BACK WITH THE MAILING KIT."

    Additional Manufacturer Narrative · 1

    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# 8113606. 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. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUES ARE UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILE BREACH OCCURRED WITH A BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FROM PHONE CALL ON 2019-09-16 14:08:13: THIS ADULT CONSUMER'S PARENT CALLED BACK WITH PRODUCT INFORMATION. CONSUMER IS VISION IMPAIRED. ITEM # 324911 WITH LOT # 8113606 FOUND ON (B)(6) 2019 1 SYRINGE WITHOUT A PLUNGER CAP OR FLANGE ON THE SYRINGE. ALSO THE NEEDLE SHIELD MISSING AND DID NOT FIND THE PIECES WITHIN THE POLY BAG. THEY CAN SEND THIS SYRINGE BACK WITH THE MAILING KIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958746 BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8113606 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other