BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19686668 · Received July 7, 2024

    Report

    Report Number
    1911916-2024-00471
    Event Type
    Malfunction
    Date Received
    July 7, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THE SCALE MARKING IS NOT PRESENT. TO AID IN THE INVESTIGATION, FIVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL SCALE IS PARTIALLY PRINTED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4080174. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIALS#: 309653 BATCH#: 4080174 IT WAS REPORTED BY THE CUSTOMER THAT SCALE MARKING IS NOT PRESENT. : RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT FACILITY: ADDRESS: CONTACT: PHONE: EMAIL: ISSUE: SCALE MARKING IS NOT PRESENT REF: 30965 LOT: 4080174 QTY: (B)(4) SAMPLE: YES, PT HARM: NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIALS#: 309653, BATCH#: 4080174. IT WAS REPORTED BY THE CUSTOMER THAT SCALE MARKING IS NOT PRESENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCTCOMPLAINT: FACILITY: XXXX XXXXX XX XXXXX. ADDRESS: XXXX XXXX XX XX XXXX XX XXXXX. CONTACT: XXXX XXX XXXX XXXX. PHONE: XXX-XXX-XXXX. EMAIL: [email protected]. ISSUE: SCALE MARKING IS NOT PRESENT. REF: 30965. LOT: 4080174. QTY: 25. SAMPLE: YES. PT HARM: NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIALS#: 309653, BATCH#: 4080174. IT WAS REPORTED BY THE CUSTOMER THAT SCALE MARKING IS NOT PRESENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCTCOMPLAINT: FACILITY: XXXX XXXXX XX XXXXX. ADDRESS: XXXX XXXX XX XX XXXX XX XXXXX. CONTACT: XXXX XXX XXXX XXXX. PHONE: XXX-XXX-XXXX. EMAIL: [email protected]. ISSUE: SCALE MARKING IS NOT PRESENT. REF: 30965. LOT: 4080174. QTY: 25. SAMPLE: YES. PT HARM: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979807 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4080174 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown