BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 9242219 · Received October 25, 2019

    Report

    Report Number
    1920898-2019-01196
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 3/10CC SYRINGE. CUSTOMER STATES THAT THEY HAVE BEEN DULL, VERY HARD TO INJECT, AND BROKEN. THE PHOTO WAS EXAMINED AND EXHIBITED A BROKEN THUMB PRESS. THE CANNULA WAS NOT SHOWN IN THE PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9014703. 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. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR SMEARED STOPPERS /DRY BARRELS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070598. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR SMEARED DRY BARRELS. 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 (BROKEN THUMB PRESS). AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 18OCT2019, HOLDREGE RECEIVED A COMPLAINT, VIA A PICTURE. VISUAL INSPECTION OF THE PICTURE FOUND (1) SYRINGE WITH THE THUMB PRESS BROKEN OFF THE PLUNGER. THE THUMBPRESS WAS BROKEN DIRECTLY UNDER THE THUMBPRESS WHERE THE THUMBPRESS AND THE ROD CONNECT. THE THUMBPRESS WAS JUST BARLEY ATTACHED TO THE ROD. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.3ML 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 HAS BEEN REPORTED THAT ONE BD ULTRA-FINE¿ INSULIN SYRINGE HAS BEEN FOUND BROKEN DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PAST FEW ORDERS SPECIFICALLY REGARDING THE 3/10ML 8MM ULTRA-FINE SYRINGES HAVE BEEN EITHER VERY DULL AND HARD TO INJECT CLIENTS, OR THEY HAVE BEEN SENT TO US BROKEN, CUSTOMER REPORTED. VERBATIM: OUR INJECTORS ON STAFF HAVE NOTICED THAT THE PAST FEW ORDERS SPECIFICALLY REGARDING THE 3/10ML 8MM ULTRA-FINE SYRINGES HAVE BEEN EITHER VERY DULL AND HARD TO INJECT CLIENTS, OR THEY HAVE BEEN SENT TO US BROKEN. UNFORTUNATELY WE DO NOT HAVE ANY OF THE DEFECTIVE NEEDLES REMAINING AS WE PLACE THEM IN THE BIOHAZARDOUS SHARPS CONTAINER IMMEDIATELY AFTER USE AND WE HAVE RECENTLY HAD THEM TAKEN OFF SITE. OUR INJECTORS ESTIMATE AROUND 2 BOXES WOULD BE THE EQUIVALENT OF THE SYRINGES WE HAD ISSUES WITH.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD ULTRA-FINE¿ INSULIN SYRINGE HAS BEEN FOUND BROKEN DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE PAST FEW ORDERS SPECIFICALLY REGARDING THE 3/10ML 8MM ULTRA-FINE SYRINGES HAVE BEEN EITHER VERY DULL AND HARD TO INJECT CLIENTS, OR THEY HAVE BEEN SENT TO US BROKEN, CUSTOMER REPORTED. VERBATIM: OUR INJECTORS ON STAFF HAVE NOTICED THAT THE PAST FEW ORDERS SPECIFICALLY REGARDING THE 3/10ML 8MM ULTRA-FINE SYRINGES HAVE BEEN EITHER VERY DULL AND HARD TO INJECT CLIENTS, OR THEY HAVE BEEN SENT TO US BROKEN. UNFORTUNATELY WE DO NOT HAVE ANY OF THE DEFECTIVE NEEDLES REMAINING AS WE PLACE THEM IN THE BIOHAZARDOUS SHARPS CONTAINER IMMEDIATELY AFTER USE AND WE HAVE RECENTLY HAD THEM TAKEN OFF SITE. OUR INJECTORS ESTIMATE AROUND 2 BOXES WOULD BE THE EQUIVALENT OF THE SYRINGES WE HAD ISSUES WITH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037091 BD ULTRA-FINE INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 9014703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other