BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

    MDR report key: 11646642 · Received April 10, 2021

    Report

    Report Number
    1920898-2021-00398
    Event Type
    Malfunction
    Date Received
    April 10, 2021
    Date of Event
    March 15, 2021
    Report Date
    March 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. TWO PHOTOS OF A LOOSE 0.3ML BD INSULIN SYRINGE WERE PROVIDED. THE CUSTOMER REPORTED THAT THE NEEDLE WITH THE SHIELD WAS SEPARATED FROM THE BARREL WHEN REMOVING THE SHIELD. BOTH PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT THE NEEDLE HUB/SHIELD ASSEMBLY WAS SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0062051 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. (B)(6) 2021, HOLDREGE RECEIVED A PHOTO COMPLAINT FROM MATERIAL #326631 AND LOT #0062051; SYRINGE 0.3ML 29GA 1/2IN. INITIAL EVALUATION: EXAMINATION OF THE PHOTO INDICATES THAT THE NEEDLE ASSEMBLY UNIT WAS NOT ATTACHED TO THE PRINTED BARREL. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, CORE PIN DAMAGE, OR DAMAGE TO THE SYRINGE. THERE DOESN¿T APPEAR TO BE EXCESSIVE ADHESIVE ON THE HUB TO CAUSE THE SHIELD TO BE DIFFICULT TO REMOVE. MANUFACTURING EVALUATION: A REVIEW OF THE SYRINGE ASSEMBLY LINE WHERE THE SYRINGE IN QUESTION WAS PRODUCED WAS COMPLETED. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS INTO A SYRINGE. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE DEVICE HISTORY (DHR) FOR BATCH 0062051 WAS REVIEWED AND ZERO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. THE SYRINGES WERE ASSEMBLED FROM 30APR2020 THRU 01MAY2020. DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: VISUAL INSPECTION EVERY HOUR: NEEDLE ASSEMBLY NOT FULLY SEATED OR IMPROPERLY SEATED ON BARREL TIP: HUB TO BARREL GAP MEASUREMENT (PIN GAUGE USED WHEN DEVIATION IS SUSPECTED). VISUAL INSPECTION EVERY HOUR: MISSING COMPONENT. VISUAL INSPECTION EVERY HOUR: DAMAGED / DEFECTIVE COMPONENTS. FUNCTIONAL INSPECTION EVERY 2 HOURS: HUB REMOVAL FORCE. IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED NOTIFICATIONS AND MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND NO DISPATCHES OR NOTIFICATIONS WERE CREATED FROM 30APR2020 THRU 01MAY2020 THAT WOULD CAUSE THE NEEDLE ASSEMBLY UNIT TO BECOME UNATTACHED. INVESTIGATION CONCLUSION: AS NO SAMPLES WERE RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. RATIONALE: CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP HUB SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT HUB SEPARATION. ACCORDING TO THE CUSTOMER'S REPORT, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL WHEN REMOVING THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543998 SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 0062051

    Patients

    Seq Age Sex Outcome Treatment
    1