BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 9554242 · Received January 6, 2020

    Report

    Report Number
    1920898-2019-01527
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 20, 2019
    Report Date
    April 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO (2) LOOSE 0.3ML BD INSULIN SYRINGES. CONSUMER REPORTED THAT THE NEEDLE SHIELD IS DIFFICULT TO REMOVE, ONCE REMOVED, THE NEEDLE HUB SEPARATES AND STAYS IN THE SHIELD. BOTH RETURNED SYRINGES WERE EXAMINED AND IT WAS OBSERVED THAT BOTH EXHIBITED SEPARATED NEEDLE HUB/SHIELD ASSEMBLIES; THE SEPARATED SHIELD ASSEMBLIES WERE NOT RETURNED, AND NO DAMAGE TO THE BARREL TIPS WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9063708. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200812519, 200813036] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, 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. DHR, L2L DISPATCHES, AND LOGBOOK ENTRIES WERE LOOKED AT, NOTHING PERTAINING TO THIS DEFECT WAS FOUND. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324909 BATCH NO: 9063708, UNKNOWN VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE, ONCE REMOVED, THE NEEDLE HUB SEPARATES AND STAYS IN THE SHIELD. CONSUMER DOES NOT REUSE. SENDING SAMPLES FOR EVALUATION. CONSUMER ALSO MENTIONED HAVING THE SAME ISSUE WITH A PREVIOUS BOX, SAME PRODUCT #. CURRENT BOX: LOT # 9063708; PRODUCT # 324909; OCCURRENCE 7. PREVIOUS BOX: PRODUCT # 324909.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: LEVEL A 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 DOES NOT ATTACH/DETACH & NEEDLE HUB SEPARATES ON LOT # 9063708. 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 #9063708. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200812519, 200813036] 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9063708, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-04, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324909 BATCH NO: 9063708, UNKNOWN. VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE, ONCE REMOVED, THE NEEDLE HUB SEPARATES AND STAYS IN THE SHIELD. CONSUMER DOES NOT REUSE. SENDING SAMPLES FOR EVALUATION. CONSUMER ALSO MENTIONED HAVING THE SAME ISSUE WITH A PREVIOUS BOX, SAME PRODUCT #. CURRENT BOX: LOT # 9063708, PRODUCT # 324909, INCIDENT DATE UNKNOWN, OCCURRENCE 7. PREVIOUS BOX: LOT # UNKNOWN, PRODUCT # 324909, INCIDENT DATE UNKNOWN, OCCURRENCE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19106 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 SEE H.10 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other