BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC

    MDR report key: 17936571 · Received October 13, 2023

    Report

    Report Number
    1920898-2023-00714
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 03NOV2023. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC THE MEDICATION COULD NOT BE PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 328418 BATCH#: 3100616 IT WAS REPORTED BY THE CONSUMER THAT FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. VERBATIM: CONSUMER COMMENTS - PREFILLS SYRINGES 10 AT A TIME. FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. CATALOG# 328418 DATE OF EVENT (B)(6) 2023 = 2 SYRINGES DATE OF EVENT UNKNOWN = 2 SYRINGES LAST WEEK SAMPLE STATUS AWAITING SAMPLE

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC THE MEDICATION COULD NOT BE PROPERLY DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 328418 BATCH#: 3100616 IT WAS REPORTED BY THE CONSUMER THAT FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. VERBATIM: CONSUMER COMMENTS - PREFILLS SYRINGES 10 AT A TIME. FOUND 2 THAT CLOGGED LAST NIGHT AND 2 THAT CLOGGED DURING INJECTION SOMETIME LAST WEEK. INFORMED CALLER TO FILL AND INJECT AS NEEDED. DON'T PREFILL AND STORE THEM. CATALOG# 328418. DATE OF EVENT 10/04/2023 = 2 SYRINGES . DATE OF EVENT UNKNOWN = 2 SYRINGES LAST WEEK . SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969046 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 8MM X 31G 1ML/CC PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 3100616 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown