BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 9444595 · Received December 10, 2019

    Report

    Report Number
    1920898-2019-01402
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 13, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 23 DECEMBER 2019 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED (2) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT THE NEEDLE HUB SEPARATED. BOTH SYRINGES WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9133810. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. A VISUAL EVALUATION OF PHOTO FOUND (2) SYRINGES WITH NO NEEDLE ASSEMBLY ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. 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. INVESTIGATION CONCLUSION 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. ROOT CAUSE DESCRIPTION L2L DISPATCH #69176 WAS CREATED FOR RAISED SHIELDS. THERE WAS DEBRIS IN THE DIAL. CORRECTIVE ACTION: THE DEBRIS WAS CLEANED OUT OF THE DIAL. RATIONALE CAPA1122103 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE NEEDLE HUB SEPARATED. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328521 BATCH NO. 9133810. IT WAS REPORTED THAT NEEDLE HUB SEPARATED. VERBATIM: RELION CONSUMER REPORTED, NEEDLE HUB SEPARATED. STATED, SHE TRIED TO SEPARATE IT WHEN IT HAPPENED BUT WAS NOT SUCCESSFUL (EXPLAINED TO CONSUMER TO NOT ATTEMPT TO PULL APART). 4 SYRINGES AFFECTED BUT ONLY 2 SAMPLES AVAILABLE. NO INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RELION® INSULIN SYRINGE NEEDLE HUB SEPARATED. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328521 BATCH NO. 9133810. IT WAS REPORTED THAT NEEDLE HUB SEPARATED. RELION CONSUMER REPORTED, NEEDLE HUB SEPARATED. STATED, SHE TRIED TO SEPARATE IT WHEN IT HAPPENED BUT WAS NOT SUCCESSFUL (EXPLAINED TO CONSUMER TO NOT ATTEMPT TO PULL APART). 4 SYRINGES AFFECTED BUT ONLY 2 SAMPLES AVAILABLE. NO INJURY REPORTED.

    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 NEEDLE HUB SEPARATED. THIS OCCURRED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328521, BATCH NO. 9133810. IT WAS REPORTED THAT NEEDLE HUB SEPARATED. VERBATIM: RELION CONSUMER REPORTED, NEEDLE HUB SEPARATED. STATED, SHE TRIED TO SEPARATE IT WHEN IT HAPPENED BUT WAS NOT SUCCESSFUL (EXPLAINED TO CONSUMER TO NOT ATTEMPT TO PULL APART). 4 SYRINGES AFFECTED BUT ONLY 2 SAMPLES AVAILABLE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243262 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328521 9133810 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other