BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 14739442 · Received June 17, 2022

    Report

    Report Number
    1920898-2022-00392
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 14, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 20 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE FROM LOT 1228522, AND ONE INSULIN SYRINGE FROM LOT 1172372 EXPERIENCED HUB SEPARATION FROM THE DEVICE. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1228522. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026. H.4. DEVICE MANUFACTURE DATE: 16-AUG-2021. D.4. MEDICAL DEVICE LOT #: 1172372. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026. H.4. DEVICE MANUFACTURE DATE: 21-JUN-2021. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 0.5ML BD INSULIN SYRINGE FROM LOT# 1228522 AND (2) 0.5ML BD INSULIN SYRINGES FROM LOT# 1172372. THE CUSTOMER REPORTED THAT THE NEEDLE HUB ASSEMBLY REMOVES WITH THE SHIELD, AND, WHEN DRAWING UP INSULIN, LEAKAGE FROM THE TOP OR THE BARREL. THE SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: 1 SYRINGE FROM LOT# 1228522 FEATURED A DETACHED NEEDLE HUB/SHIELD ASSEMBLY WITH NO DAMAGE TO THE BARREL TIP 1 SYRINGE FROM LOT# 1172372 FEATURED A BROKEN BARREL TIP 1 SYRINGE FROM LOT# 1172372 FEATURED TWO CRACKS IN THE BARREL SPANNING THE LENGTH BETWEEN THE 0- AND 10- UNIT MARKINGS MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THE OBSERVED HUB SEPARATES ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1228522. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200975714] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - CONFIRMED: EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. DATE COMPLAINT RECEIVED IN HOLDREGE: (B)(6) 2022 CATALOG AND BATCH #: 328468 AND 1228522 CATALOG DESCRIPTION: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS ISSUE: HUB SEPARATES. ANALYSIS OF SAMPLE: BASED ON RETURNED SAMPLE ANALYSIS FROM COMPLAINT HANDLING DEPARTMENT, SYRINGE WAS EXAMINED AND EXHIBITED THAT IT HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. PROCESS: 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. INVESTIGATION: THERE WAS ONE (1) NOTIFICATION [200975714] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. REVIEWED L2L (LEADING TO LEAN) MAINTENANCE DISPATCH HISTORY AND DID NOT FIND ANY DISPATCHES PERTAINING TO DEFECT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE ACTION- CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. QUALITY: 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 20 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT WHEN NEEDLE SHIELD WAS REMOVED THE NEEDLE HUB ASSEMBLY REMOVES WITH THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLE FROM LOT 1228522, AND ONE INSULIN SYRINGE FROM LOT 1172372 EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT WHEN NEEDLE SHIELD WAS REMOVED THE NEEDLE HUB ASSEMBLY REMOVES WITH THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224526 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 SEE SECTION H10 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown