BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 9695991 · Received February 11, 2020

    Report

    Report Number
    1920898-2020-00112
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 14, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 9112698. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. H.4. DEVICE MANUFACTURE DATE: 2019-04-22. D.4. MEDICAL DEVICE LOT #: 8351988. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. H.4. DEVICE MANUFACTURE DATE: 2018-12-17. H.6. INVESTIGATION: CUSTOMER RETURNED (26) 3/10CC, 8MM, 31G SYRINGES IN OPEN POLY BAGS FROM LOT # 9112698 AND (6) 3/10CC, 8MM, 31G SYRINGES IN OPEN POLY BAGS FROM LOT # 8351988. CUSTOMER STATES THAT LIQUID IS COMING OUT OF NEEDLE WHEN DEPRESSING PLUNGER. ALL RETURNED SYRINGES WERE TESTED AND 14 OUT OF 26 SYRINGES FROM LOT # 9112698 AND 2 OUT OF 6 SAMPLES FROM LOT # 8351988 EXHIBITED A SMALL CLEAR DROPLET OF MATERIAL COMING OUT OF THE BARREL WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM A SAMPLE FROM EACH LOT NUMBER AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8351988. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200802100] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9112698. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 1/2CC, 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. BATCH 835198: ROOT CAUSE: AIR IN THE SILICONE APPLICATION LINES. NOTIFICATION 200802100 WAS CREATED DURING THE CREATION OF THIS LOT FOR DRY BARRELS. THIS ROOT CAUSE COULD ALSO CREATE POOLING. CORRECTION: THE SILICONE APPLICATION LINES WERE PURGED TO REMOVE THE AIR FROM THE LINES.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 20 FEBRUARY 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. UNABLE TO PERFORM A DHR REVIEW DUE TO AN UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: 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 · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD FOREIGN MATTER COMING OUT OF IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438, BATCH NO. UNKNOWN. IT WAS REPORTED THAT LIQUID IS COMING OUT OF NEEDLE WHEN DEPRESSING PLUNGER. ISSUE(S): FOUND FROM 2 DIFFERENT BOXES LIQUID COMING OUT OF NEEDLE BEFORE DRAWING UP INSULIN AND WHEN PRESSING THE PLUNGER TO THE TOP OF SYRINGE. CONSUMER IS VISION IMPAIRED COULD NOT READ THE NUMBERS ON THE BAGS. HAS 14 BAGS WITH 2-3 SYRINGES WITHIN EACH BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD FOREIGN MATTER COMING OUT OF IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438 BATCH NO. UNKNOWN IT WAS REPORTED THAT LIQUID IS COMING OUT OF NEEDLE WHEN DEPRESSING PLUNGER. VERBATIM: ISSUE(S): FOUND FROM 2 DIFFERENT BOXES LIQUID COMING OUT OF NEEDLE BEFORE DRAWING UP INSULIN AND WHEN PRESSING THE PLUNGER TO THE TOP OF SYRINGE. CONSUMER IS VISION IMPAIRED COULD NOT READ THE NUMBERS ON THE BAGS. HAS 14 BAGS WITH 2-3 SYRINGES WITHIN EACH BAG

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD FOREIGN MATTER COMING OUT OF IT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438 BATCH NO. UNKNOWN. IT WAS REPORTED THAT LIQUID IS COMING OUT OF NEEDLE WHEN DEPRESSING PLUNGER. VERBATIM: ISSUE(S): FOUND FROM 2 DIFFERENT BOXES LIQUID COMING OUT OF NEEDLE BEFORE DRAWING UP INSULIN AND WHEN PRESSING THE PLUNGER TO THE TOP OF SYRINGE. CONSUMER IS VISION IMPAIRED COULD NOT READ THE NUMBERS ON THE BAGS. HAS 14 BAGS WITH 2-3 SYRINGES WITHIN EACH BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160418 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 SEE H.10 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other