BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 9511418 · Received December 23, 2019

    Report

    Report Number
    1920898-2019-01463
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 6, 2019
    Report Date
    February 14, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (20) 31GX6MM, 0.3ML BD INSULIN SYRINGES: 10 WERE RETURNED LOOSE, AND 10 WERE RETURNED IN A SEALED POLYBAG FROM LOT 9063708. CONSUMER STATED, SHE REMOVED THE PLUNGER CAP AND PUSHED ON THE PLUNGER, CLEAR LIQUID CAME OUT. ALL 20 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT A CLEAR LIQUID CAME OUT OF THE CANNULA FROM 8 OF THE SYRINGES THAT WERE RETURNED LOOSE; NONE OF THE 10 SYRINGES RETURNED IN THE SEALED POLYBAG EXHIBITED A CLEAR LIQUID COME OUT FROM THE CANNULA. A SMALL PORTION OF THE LIQUID WAS REMOVED THEN PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF SILICONE. 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 [200812519, 200813036] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (EXCESSIVE LUBRICATION/SILICONE) FOR SAMPLES FROM UNKNOWN LOT NUMBER. UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE FOR SAMPLES FROM LOT 9063708. 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. ROOT CAUSE: AIR BUBBLES IN THE SILICONE GUNS. CORRECTIVE ACTION: L2L DISPATCH #61654 WAS CREATED TO PURGE THE SILICONE GUN. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 9 JANUARY 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 [200812519, 200813036] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    MATERIAL NO. 324909, BATCH NO. 9063708, UNKNOWN. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 0.3ML 31GA 6MM WHOLE UNIT 10BAG A CLEAR LIQUID CAME OUT OF NEEDLE WHEN PUSHING ON THE PLUNGER. THERE WERE EIGHT SYRINGES WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, SHE REMOVED THE PLUNGER CAP AND PUSHED ON THE PLUNGER, CLEAR LIQUID CAME OUT. SHE DID NOT USE SYRINGE WHEN THAT HAPPENED. 8 SYRINGES AFFECTED LOT: 9063708, ITEM: 324909, EXPIRATION DATE: 2024-03-31. THERE WAS A SECOND BOX" HOW MANY SYRINGES AFFECTED, UNKNOWN ITEM: 324909 LOT: UNKNOWN.

    Description of Event or Problem · 0

    MATERIAL NO. 324909 BATCH NO. 9063708, UNKNOWN. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 0.3ML 31GA 6MM WHOLE UNIT 10 BAG A CLEAR LIQUID CAME OUT OF NEEDLE WHEN PUSHING ON THE PLUNGER. THERE WERE EIGHT SYRINGES WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, SHE REMOVED THE PLUNGER CAP AND PUSHED ON THE PLUNGER, CLEAR LIQUID CAME OUT. SHE DID NOT USE SYRINGE WHEN THAT HAPPENED. 8 SYRINGES AFFECTED LOT: 9063708 ITEM: 324909 EXPIRATION DATE: 2024-03-31 THERE WAS A SECOND BOX" HOW MANY SYRINGES AFFECTED, UNKNOWN ITEM: 324909 LOT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9063708, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2019-03-04. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 324909, BATCH NO. (B)(4), UNKNOWN. IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG A CLEAR LIQUID CAME OUT OF NEEDLE WHEN PUSHING ON THE PLUNGER. THERE WERE EIGHT SYRINGES WITH THIS ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, SHE REMOVED THE PLUNGER CAP AND PUSHED ON THE PLUNGER, CLEAR LIQUID CAME OUT. SHE DID NOT USE SYRINGE WHEN THAT HAPPENED. 8 SYRINGES AFFECTED LOT: 9063708 ITEM: 324909 EXPIRATION DATE: 2024-03-31 THERE WAS A SECOND BOX" HOW MANY SYRINGES AFFECTED, UNKNOWN ITEM: 324909 LOT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308760 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 SEE SECTION H.10 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other