BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10963828 · Received December 7, 2020

    Report

    Report Number
    1920898-2020-01676
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 12, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    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 · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-28. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (5) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THERE IS LIQUID INSIDE OF THE SYRINGE. ALL RETURNED SYRINGES WERE EXAMINED AND 2 OUT OF 5 SAMPLES EXHIBITED A SMALL, CLEAR DROPLET OF MATERIAL COME OUT OF THE CANNULA. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE 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 # 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200884826, 200884828] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.3ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS INTO A SYRINGE. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. AT THE LUBRICATION DIAL, THE PRINTED BARREL IS RECEIVED TO THE BARREL PREP DIAL WHERE AIR PASSES FROM PROBES AND BLOWS OUT ANY FM THAT MAY BE WITHIN THE BARREL ID DOWNWARD AND OUT THROUGH THE TIP. ONCE THIS IS COMPLETED, THE PRINTED BARREL INDEXES UNDER THE SINGLE SILICONE GUN WHERE A SHOT OF SILICONE IS SPRAYED INTO THE PRINTED BARREL ID. DEVICE HISTORY RECORD; L2L AND LOGBOOK EVALUATION: THE DEVICE HISTORY (DHR) FOR BATCH 0083507 WAS REVIEWED AND ZERO QUALITY NOTIFICATIONS WERE WRITTEN FOR ISSUES RELATING TO THE ASSEMBLED SYRINGE DEFECT. THE SYRINGES WERE ASSEMBLED FROM 20MAY2020 THRU 23MAY2020 DURING THE MANUFACTURING PROCESS, THE FOLLOWING INSPECTIONS ARE COMPLETED ON REGULAR INTERVALS: 1. VISUAL INSPECTION (WITHOUT AID) EVERY 2 HOURS: EXCESSIVE BARREL LUBRICANT AS EVIDENCED BY ¿POOLING¿ OR FORMATION OF DROPLETS 2. VISUAL INSPECTION EVERY 2 HOUR: BARREL LUBRICANT SHALL BE ON THE INSIDE SURFACES OF THE SYRINGE ONLY IF A DEFECT IS FOUND DURING AN INSPECTION A QUALITY NOTIFICATION IS INITIATED NOTIFICATIONS WERE REVIEWED, AND NO NONCONFORMANCES WERE NOTED FROM 20MAY2020 THRU 23MAY2020 THAT WOULD CAUSE EXCESSIVE LUBRICANT. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) #97787 WAS CREATED ON 23MAY2020 FOR EXCESSIVE SILICON BEING PUT IN THE BARRELS. CORRECTIVE ACTION: PURGED ALL 9 SILICONE GUNS. CAPA1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE IS LIQUID INSIDE OF THE SYRINGE, STATED THAT SHE NOTICED IT WHEN SHE DEPRESSED THE PLUNGER ROD. LOT #: 0083507. CATALOG #: 324910. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THERE IS LIQUID INSIDE OF THE SYRINGE, STATED THAT SHE NOTICED IT WHEN SHE DEPRESSED THE PLUNGER ROD. LOT #: 0083507. CATALOG #: 324910. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427799 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083507

    Patients

    Seq Age Sex Outcome Treatment
    1