BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 9540352 · Received January 2, 2020

    Report

    Report Number
    1920898-2019-01506
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 17, 2019
    Report Date
    January 21, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER ROD DIFFICULT TO MOVE AND OTHER (ORANGE CAP LOOKS DIFFERENT) FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 EXPERIENCED DIFFICULTY MOVING THE PLUNGER ROD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328438; BATCH NO: 9112698. VERBATIM: ISSUE: STAFF REPORTED SHE IS HAVING DIFFICULTY PUSHING THE PLUNGER BETWEEN 1 TO 4 UNITES SHE HAS RESISTANCE. ORANGE CAP LOOKS DIFFERENT. IF THERE IS ANY CHANGES IN THE DESIGN. SHE INQUIRED IF THERE IS ANY TRICK TO PUSH THE PLUNGER EASILY. INCIDENT DATE -UNKNOWN; OCCURENCE-UNKNOWN; ITEM# 328438; LOT# 9112698; EXPIRATIONDATE-5-31-2024. USES NEW SYRINGES EACH TIME OF THEIR TREATMENT. THEY USE IT FOR TREATMENT. EXPLAINED THE CALLER, THESE SYRINGES ARE FOR INSULIN. THEY ARE USING FOR OFF LABEL USE. CALLER PUT ME ON HOLD TO GET NAME OF THE MEDICATION, BUT CALL DISCONNECTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 EXPERIENCED DIFFICULTY MOVING THE PLUNGER ROD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328438, BATCH NO: 9112698. VERBATIM: ISSUE: STAFF REPORTED SHE IS HAVING DIFFICULTY PUSHING THE PLUNGER BETWEEN 1 TO 4 UNITES SHE HAS RESISTANCE. ORANGE CAP LOOKS DIFFERENT. IF THERE IS ANY CHANGES IN THE DESIGN. SHE INQUIRED IF THERE IS ANY TRICK TO PUSH THE PLUNGER EASILY. INCIDENT DATE -UNKNOWN, OCCURENCE-UNKNOWN, ITEM# 328438, LOT# 9112698; EXPIRATION DATE-5-31-2024. USES NEW SYRINGES EACH TIME OF THEIR TREATMENT. THEY USE IT FOR TREATMENT. EXPLAINED THE CALLER, THESE SYRINGES ARE FOR INSULIN. THEY ARE USING FOR OFF LABEL USE. CALLER PUT ME ON HOLD TO GET NAME OF THE MEDICATION, BUT CALL DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4980 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9112698 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other