BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 6MM 10BAG 500CS

    MDR report key: 9446596 · Received December 10, 2019

    Report

    Report Number
    1920898-2019-01405
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 29, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) LOOSE 31GX6MM, 0.5ML BD INSULIN SYRINGE FROM LOT 9063699. CONSUMER REPORTED FINDING A DAMAGED PLUNGER ROD; STATED, WHEN HE REMOVED THE CAP, THE "FLAT PART" THAT YOU PUSH ON IS MISSING. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE PLUNGER ROD WAS BROKEN. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063699. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812524] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. VISUAL INSPECTION OF THE SYRINGE FOUND THE TOP 5/8¿ OF THE PLUNGER TO BE BROKEN OFF. THERE WERE WHITE STRESS MARKS ON THE PLUNGER AROUND THE BREAK POINT. THERE WAS A CLOUDY FLUID IN THE SYRINGE TO ABOUT THE 3 UNIT SCALE LINE. THE PLUNGER WAS EXERCISED AND DEMONSTRATED SMOOTH MOVEMENT INSIDE THE BARREL INDICATING ADEQUATE SILICONE. PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.5ML 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: THE ALARM AT THE EJECT SHOOT WHERE SYRINGES WITH MISSING PLUNGERS GETS KICKED OFF WAS NOT WORKING AND THE EJECT SHOOT BECAME PLUGGED. CORRECTION: L2L DISPATCH #61191 ON JT METRO WAS CREATED ADJUST THE EYE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 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# 9063699. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812524] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 0.5ML 31GA 6MM 10BAG 500CS HAS BEEN FOUND DAMAGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THUMB PRESS BROKE OFF OF PLUNGER ROD. VERBATIM: CONSUMER REPORTED FINDING A DAMAGED PLUNGER ROD STATED, WHEN HE REMOVED THE CAP, THE "FLAT PART" THAT YOU PUSH ON IS MISSING. COULD NOT USE SYRINGE. 1 SYRINGE AFFECTED; INCIDENT DATE: (B)(6) 2019; LOT: 9063699; ITEM: 324911; EXPIRATION DATE: 2023-03-31.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 0.5ML 31GA 6MM 10BAG 500CS HAS BEEN FOUND DAMAGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THUMB PRESS BROKE OFF OF PLUNGER ROD. VERBATIM: CONSUMER REPORTED FINDING A DAMAGED PLUNGER ROD. STATED, WHEN HE REMOVED THE CAP, THE "FLAT PART" THAT YOU PUSH ON IS MISSING. COULD NOT USE SYRINGE. 1 SYRINGE AFFECTED. INCIDENT DATE: (B)(6) 2019, LOT: 9063699, ITEM: 324911, EXPIRATION DATE: 2023-03-31.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE BD¿ SYRINGE 0.5ML 31GA 6MM 10BAG 500CS HAS BEEN FOUND DAMAGED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THUMB PRESS BROKE OFF OF PLUNGER ROD. VERBATIM: CONSUMER REPORTED FINDING A DAMAGED PLUNGER ROD STATED, WHEN HE REMOVED THE CAP, THE "FLAT PART" THAT YOU PUSH ON IS MISSING. COULD NOT USE SYRINGE. 1 SYRINGE AFFECTED. INCIDENT DATE: (B)(6) 2019. LOT: 9063699. ITEM: 324911. EXPIRATION DATE: 2023-03-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243395 BD SYRINGE 0.5ML 31GA 6MM 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 9063699 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other