BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13625204 · Received February 28, 2022

    Report

    Report Number
    1920898-2022-00133
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 22, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-03-08. INVESTIGATION SUMMARY: CUSTOMER RETURNED (94) 3/10CC, 6MM, 31G SYRINGES (44 LOOSE, 50 IN SEALED POLY BAGS) FROM LOT # 1242719. CUSTOMER STATES THAT THE STOPPER IS DAMAGED AND NOT SITTING FLUSH ON THE PLUNGER. ALL RETURNED SAMPLES WERE EXAMINED AND ALL LOOSE SAMPLES AND 44 OUT OF 50 SAMPLES IN THE SEALED POLY BAGS EXHIBITED A DEFORMED STOPPER IN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 1242719 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) #132263 WAS CREATED FOR POTENTIAL DRY BARRELS. DRY BARRELS INDICATE A LACK OF SILICONE INSIDE THE BARREL TO ALLOW MOVEMENT OF THE PLUNGER/STOPPER ROD. FOUND A SILICONE GUN NOT ALIGNED CORRECTLY. NO ROOT CAUSE AS TO WHY THE GUN WAS SIGHTLY OUT OF LINE TO THE SILICONE BEING APPLIED INTO THE BARREL. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD A DEFORMED STOPPER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PHARMACY REPORTED ON BEHALF OF THE CONSUMER A DAMAGED STOPPER IN THAT THE STOPPER DOES NOT SIT FLUSH ON THE PLUNGER. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD A DEFORMED STOPPER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PHARMACY REPORTED ON BEHALF OF THE CONSUMER A DAMAGED STOPPER IN THAT THE STOPPER DOES NOT SIT FLUSH ON THE PLUNGER. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299155 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown