BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 9481119 · Received December 17, 2019

    Report

    Report Number
    1920898-2019-01436
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    December 2, 2019
    Report Date
    April 6, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 3 JANUARY 2020 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 #9133810. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200827854] NOTED FOR CRACKED HUBS. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (2) 3/10CC, 6MM, 31G RELION SYRINGES IN OPEN POLY BAGS FROM LOT # 9133810. CUSTOMER STATES THAT THE NEEDLE SHIELD IS DIFFICULT TO REMOVE AND ONCE REMOVED THE NEEDLE HUB SEPARATES FROM THE SYRINGE INTO THE SHIELD. ONE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. THE REMAINING SYRINGE WAS TESTED TO DETERMINE THE SHIELD REMOVAL FORCES (SPECS: SHIELD REMOVAL FORCE FOR 3/10CC AFTER STERILIZATION: 0.85-5.95 LBS.). THE SHIELD REMOVAL FORCE WAS MEASURED AS 4.92 LBS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9133810. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200827854] NOTED FOR CRACKED HUBS. 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. ROOT CAUSE: L2L DISPATCH #69176 WAS CREATED FOR RAISED SHIELDS. THERE WAS DEBRIS IN THE DIAL. CORRECTIVE ACTION: THE DEBRIS WAS CLEANED OUT OF THE DIAL. CAPA#1122103 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE HUB SEPARATES FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328521 BATCH NO. 9133810 IT WAS REPORTED THAT NEEDLE SHIELD IS DIFFICULT TO REMOVE AND ONCE REMOVED THE NEEDLE HUB SEPARATES FROM THE SYRINGE INTO THE SHIELD. VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE, ONCE REMOVED, THE HUB SEPARATES AND STAYS IN THE SHIELD. CONSUMER DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE HUB SEPARATES FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328521, BATCH NO. 9133810. IT WAS REPORTED THAT NEEDLE SHIELD IS DIFFICULT TO REMOVE AND ONCE REMOVED THE NEEDLE HUB SEPARATES FROM THE SYRINGE INTO THE SHIELD. VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE, ONCE REMOVED, THE HUB SEPARATES AND STAYS IN THE SHIELD. CONSUMER DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 WAS REPORTED THAT RELION® INSULIN SYRINGE HUB SEPARATES FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328521, BATCH NO. 9133810. IT WAS REPORTED THAT NEEDLE SHIELD IS DIFFICULT TO REMOVE AND ONCE REMOVED THE NEEDLE HUB SEPARATES FROM THE SYRINGE INTO THE SHIELD. VERBATIM: CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE, ONCE REMOVED, THE HUB SEPARATES AND STAYS IN THE SHIELD. CONSUMER DOES NOT RE-USE, SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280112 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 9133810 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other