BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT

    MDR report key: 9934257 · Received April 8, 2020

    Report

    Report Number
    1920898-2020-00353
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 18, 2020
    Report Date
    April 15, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT SHIELDS ARE DIFFICULT TO REMOVE FROM ALL SYRINGES HE HAS USED SO FAR STATED, WHEN HE REMOVED SHIELD ON SOME OF THEM, THE NEEDLE AND HUB STAYED INSIDE SHIELD. ALL SYRINGES WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9252570. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED FOR HIGH SHIELD PULL. 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 [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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: A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLIES ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE CORE PIN. 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. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES THAT PERTAINED TO THIS DEFECT DURING THE PRODUCTION OF THIS BATCH. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. (B)(4) WAS IMPLEMENTED ON (B)(6) 2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA 1122103 WAS BEEN OPENED ON (B)(6) 2019 TO ADDRESS THIS ISSUE." H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 6MM WHOLE UNIT EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324909. BATCH NO: 9252570 & 9063708. VERBATIM: CONSUMER REPORTED, SHIELDS ARE DIFFICULT TO REMOVE FROM ALL SYRINGES HE HAS USED SO FAR STATED, WHEN HE REMOVED SHIELD ON SOME OF THEM, THE NEEDLE AND HUB STAYED INSIDE SHIELD, WAS NOT ABLE USE 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9252570, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-09-09, MEDICAL DEVICE LOT #: 9063708, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-04.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 6MM WHOLEUNIT EXPERIENCED HUB SEPARATION FROM THE DEVICE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324909 BATCH NO: 9252570 & 9063708. VERBATIM: CONSUMER REPORTED, SHIELDS ARE DIFFICULT TO REMOVE FROM ALL SYRINGES HE HAS USED SO FAR STATED, WHEN HE REMOVED SHIELD ON SOME OF THEM, THE NEEDLE AND HUB STAYED INSIDE SHIELD, WAS NOT ABLE USE. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400045 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 SEE H.10 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other