BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10731293 · Received October 23, 2020

    Report

    Report Number
    1920898-2020-01470
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908466035
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0111947, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-20, MEDICAL DEVICE LOT #: 9280130, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-10-07, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR THUMBPRESS BREAKS OFF DURING USE AND FLANGE DAMAGED ON LOT # 0111947 AND THE 1ST FOR HUB SEPARATES FOR LOT # 9280130. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR PLUNGER ROD SEPARATES FOR UNKNOWN LOT NUMBER. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, THUMBPRESS BREAKS OFF DURING USE, FLANGE DAMAGED, HUB SEPARATES AND PLUNGER ROD SEPARATES) WAS CAPTURED AND ADDRESSED INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0111947. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9280130. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLES EXPERIENCED HUB SEPARATION FROM THE DEVICE, A PLUNGER THAT WAS LOOSE/FELL OUT/SEPARATED, BROKEN THUMB PRESS, AND DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328466 BATCH NO. 0111947, 9280130, UNKNOWN. DATE OF EVENT: UNKNOWN. I RETURNED CONSUMER'S CALL AND HE STATED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD AND THE THUMB PRESS WAS DAMAGED, ADDING THAT PART OF THE THUMB PRESS CAME OFF, LEAVING A SHARP EDGE. CONSUMER STATED THAT THE NEEDLE SHIELD WAS NOT DIFFICULT TO REMOVE. HE ALSO MENTIONED THAT IN THE PAST THE PLUNGER ROD CAME OUT OF THE SYRINGE WHEN CAP WAS REMOVED. STATED THAT THIS OCCURRED A WHILE AGO, PACKAGING AND SAMPLES HAVE BEEN DISCARDED. CONSUMER DOES NOT REMEMBER WHICH PRODUCT IT WAS, HE JUST MENTIONED IT AS HE WAS REPORTING THE CURRENT ISSUE. CURRENT ISSUE INVOLVES TWO BOXES WITH DIFFERENT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196213 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328466 SEE H10 00382908466035

    Patients

    Seq Age Sex Outcome Treatment
    1