BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML 31GX6MM U-100 INSULIN SYRINGE

    MDR report key: 9251666 · Received October 29, 2019

    Report

    Report Number
    1920898-2019-01207
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 1, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) LOOSE 1CC, 6MM SYRINGES. CUSTOMER STATES THAT THE PLUNGER ROD IS TOO STIFF AND HARD TO PULL TO DRAW AIR AND INSULIN. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8142702. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE 1ML 31GX6MM U-100 INSULIN SYRINGE HAS BEEN FOUND EXPERIENCING 48 OCCURRENCES OF DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328519, BATCH NO: 8142702, UNKNOWN. IT WAS REPORTED PLUNGER ROD IS TOO STIFF HARD TO PULL TO DRAW AIR AND INSULIN. VERBATIM: ISSUE: SPOUSE OF A CONSUMER REPORTED PLUNGER ROD IS TOO STIFF HARD TO PULL TO DRAW AIR AND INSULIN. SAMPLE AVAILABLE. CONSUMER USES THE 1ML, 31G,6MM SYRINGES. IT HAPPENED WITH HIS 2 BOXES. 1ST BOX (LOT# UNKNOWN), INCIDENT DATE: (B)(6) 2019, OCCURRENCE: (B)(4). 2ND BOX (LOT# 8142702), INCIDENT DATE: (B)(4) 2019, OCCURRENCE: (B)(4). CONSUMER USES NEW SYRINGES EACH TIME OF HIS INJECTION. SHE STATED THE FIRST BOX SYRINGES WERE LITTLE MORE HARDER TO PULL THE PLUNGER ROD THAN THE FIRST BOX.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8142702, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 2018-08-08, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 THE 1ML 31GX6MM U-100 INSULIN SYRINGE HAS BEEN FOUND EXPERIENCING 48 OCCURRENCES OF DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328519 BATCH NO: 8142702, UNKNOWN. IT WAS REPORTED PLUNGER ROD IS TOO STIFF HARD TO PULL TO DRAW AIR AND INSULIN. VERBATIM: ISSUE: SPOUSE OF A CONSUMER REPORTED PLUNGER ROD IS TOO STIFF HARD TO PULL TO DRAW AIR AND INSULIN. SAMPLE AVAILABLE. CONSUMER USES THE 1ML, 31G,6MM SYRINGES. IT HAPPENED WITH HIS 2 BOXES. 1ST BOX (LOT# UNKNOWN). INCIDENT DATE: (B)(6) 2019. OCCURRENCE: 35. 2ND BOX (LOT# 8142702) INCIDENT DATE-(B)(6) 2019 OCCURRENCE-13 CONSUMER USES NEW SYRINGES EACH TIME OF HIS INJECTION. SHE STATED THE FIRST BOX SYRINGES WERE LITTLE MORE HARDER TO PULL THE PLUNGER ROD THAN THE FIRST BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048147 1ML 31GX6MM U-100 INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 Other