BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G TW 6MM BLS 400 SG

    MDR report key: 21811062 · Received April 9, 2025

    Report

    Report Number
    3024508819-2025-00173
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Report Date
    April 22, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT IS BOTH AN INITIAL AND FINAL SUBMISSION AS THE INVESTIGATION HAS BEEN COMPLETED. 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 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. 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) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4 AND G6. CORRECTION MADE TO H10 TO INCLUDED REFERENCED FDA MEDWATCH REPORT 4600150000-2025-8001.

    Description of Event or Problem · 0

    FDA MEDWATCH REPORT (B)(4) ATTACHMENTS IN FILE. DESCRIBE THE EVENT OR PROBLEM: NURSE ATTEMPTED TO REMOVE CAP OFF OF 30ML INSULIN SYRINGE, ORANGE CAP CAME OFF AS DID NEEDLE SAFETY DEVICE. NEEDLE WAS BENT. HOSPITAL REPORTING TO FDA. LOT #: 4103073; CATALOG#: 328449; SYRINGE INSULIN 0.3ML 31GAX0.25IN SAFETYGLIDE. DATE OF FDA REPORT MARCH 2025. SAMPLE STATUS DISCARD. DEAR TEAM, PLEASE LOOK INTO THIS REQUEST. CUSTOMER SUPPORT: ON TUE, MAR 18 10:53 AM, REGULATORY.AFFAIRS, [email protected], WROTE: HI, PLEASE ASSIGN IT TO (B)(6). REGARDS, CUSTOMER SUPPORT. FROM: REGULATORY AFFAIRS <[email protected]> SENT: TUESDAY, MARCH 18, 2025 7:39 PM TO: PRODUCTCOMPLAINTS <[email protected]> SUBJECT: FW: (B)(4). HELLO, PLEASE SEE BELOW. (B)(6) SENIOR MANAGER, REGULATORY AFFAIRS AND OPERATIONS, (B)(6) MOBILE. FROM: FDA ORIGINATED LETTERS, [email protected]. SENT: TUESDAY, MARCH 18, 2025 9:23 AM TO: REGULATORY AFFAIRS, [email protected]. SUBJECT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816341 SYRINGE 0.3ML 31G TW 6MM BLS 400 SG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328449 4103073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown