BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19861742 · Received July 30, 2024

    Report

    Report Number
    1911916-2024-00553
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS PRODUCT WITH NO MARKINGS. TO AID IN THE INVESTIGATION, FIVE SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARRELS HAVE NO SCALE PRINTED. THE PHOTO PROVIDED SHOWS EIGHT SYRINGES IN THEIR PACKAGING BLISTERS. SEVEN OF THE SYRINGES HAVE NO SCALE MARKING, AND THE EIGHTH SYRINGE HAS THE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS INDUCING A MISALIGNMENT OF THE PRINTING PAD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4151249. 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 SAMPLES 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.

    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

    PR (B)(6) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE IS PRODUCT WITH NO MARKINGS. TO AID IN THE INVESTIGATION, TWELVE SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARRELS HAVE NO SCALE PRINTED. THE PHOTO PROVIDED SHOWS EIGHT SYRINGES IN THEIR PACKAGING BLISTERS. SEVEN OF THE SYRINGES HAVE NO SCALE MARKING, AND THE EIGHTH SYRINGE HAS THE MARKING. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE SYRINGE BARREL PRINTING PROCESS INDUCING A MISALIGNMENT OF THE PRINTING PAD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4151249. 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 SAMPLES 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

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 309653; BATCH # 4151249. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE LUER-LOCK PRODUCT WITH NO MARKINGS. VERBATIM: CUSTOMER REPORTED NEW FACILITY THAT HAS PRODUCT WITH NO MARKINGS. GOOD MORNING BD TEAM, I HAVE CC¿D AT WHO ALSO HAS AFFECTED LUER-LOCK PRODUCT., PLEASE WORK WITH JUSTIN IF YOU WOULD LIKE THOSE IMPACTED SYRINGES AS WELL. NO MARKINGS ON THE SYRINGES. NO MEANS OF MEASUREMENT OF FLUID PULLED INTO THE SYRINGE.

    Description of Event or Problem · 0

    MATERIAL # 309620 BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE LUER-LOCK PRODUCT WITH NO MARKINGS. VERBATIM: CUSTOMER REPORTED NEW FACILITY YYYYYYY THAT HAS PRODUCT WITH NO MARKINGS. GOOD MORNING BD TEAM, I HAVE CC¿D XXXXX AT YYYYYYY WHO ALSO HAS AFFECTED LUER-LOCK PRODUCT. ZZZZZZZ, PLEASE WORK WITH JUSTIN IF YOU WOULD LIKE THOSE IMPACTED SYRINGES AS WELL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL # 309653; BATCH # 4151249. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE LUER-LOCK PRODUCT WITH NO MARKINGS. VERBATIM: CUSTOMER REPORTED NEW FACILITY YYYYYYY THAT HAS PRODUCT WITH NO MARKINGS. GOOD MORNING BD TEAM, I HAVE CC¿D XXXXX AT YYYYYYY WHO ALSO HAS AFFECTED LUER-LOCK PRODUCT. ZZZZZZZ, PLEASE WORK WITH JUSTIN IF YOU WOULD LIKE THOSE IMPACTED SYRINGES AS WELL. NO MARKINGS ON THE SYRINGES.. NO MEANS OF MEASUREMENT OF FLUID PULLED INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244131 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4151249 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown