BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11547885 · Received March 22, 2021

    Report

    Report Number
    1920898-2021-00331
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 21, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: 32 - 991020388 DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2021 . AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON (B)(6) 2021 VIA THE BD INVESTIGATION THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1/2CC SYRINGE. CUSTOMER STATES THAT THE SYRINGE HAS COME DISASSEMBLED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140642. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200826647] 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 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. (B)(6) 2021 , HOLDREGE RECEIVED A PHOTO COMPLAINT FROM MATERIAL #324917 AND LOT #9140642; SYRINGE 0.5ML 31GA 6MM. 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. THE SHIELD WAS ATTACHED TO THE HUB/CANNULA UNIT THEREFORE NO EXAMINATION COULD BE COMPLETED FOR DAMAGE OR EXCESSIVE ADHESIVE 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 0.5ML 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 9140642 WAS REVIEWED AND ZERO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. THE SYRINGES WERE ASSEMBLED FROM 11JUL2019 TO 13JUL2019. 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. MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND NO DISPATCHES WERE CREATED FROM 11JUL2019 TO 13JUL2019 THAT WOULD CAUSE THE NEEDLE ASSEMBLY UNIT TO BECOME UNATTACHED. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. DHR, L2L DISPATCHES, LOGBOOK ENTRIES WERE LOOKED AT, NOTHING WAS FOUND PERTAINING TO THIS DEFECT. CAPA# (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE SYRINGE HAS COME DISASSEMBLED, WITHOUT THE PLUNGER, WITHOUT THE NEEDLE, AND ITS UPPER PART IS BROKEN. THE NEEDLE HAS COME WITH THE ITEMS SEPARATED. CUSTOMER ALWAYS BUYS AND IT HAS NEVER HAPPENED BEFORE, HIS SON IS WHO USES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444429 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9140642

    Patients

    Seq Age Sex Outcome Treatment
    1