BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 10577921 · Received September 23, 2020

    Report

    Report Number
    1213809-2020-00651
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    September 2, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/14/2020. H.6. INVESTIGATION: ONE LOOSE 10ML SYRINGE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LENGTHWISE CRACK IN THE BARREL, OUTSIDE THE GRAD LINES, EXTENDING FROM THE 2ML TO THE 5ML MARKING. THE CRACK WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED LEAKAGE AND DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; LOTS# 0091899 OR 9301110 OR 0062714. JET OF WATER AND BLOOD COMING FROM THE SIDE OF THE SYRINGE DURING ITS USE DURING A STERILE PROCEDURE (RINSING OF THE FEMORAL THREAD 8F). 3 LOTS ARE POSSIBLE BUT PACKAGING ARE DISCARDED. WAS THERE ANY CONSEQUENCES FOR THE PATIENT? NO. WAS THERE EXPOSURE TO BLOOD? -BLOOD SPILL IN THE DIRECTION OF THE CAREGIVER. THERE WAS CONTACT ON THE STERILE GOWN OF THE CAREGIVER. MEDICAL INTERVENTION OR CHANGE OF TREATMENT? NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. . A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS THAT WERE POTENTIALLY INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0091899, MEDICAL DEVICE EXPIRATION DATE: 02/28/2025 DEVICE MANUFACTURE DATE: 04/02/2020. MEDICAL DEVICE LOT #: 9301110, MEDICAL DEVICE EXPIRATION DATE: 10/31/2024, DEVICE MANUFACTURE DATE: 11/11/2019. MEDICAL DEVICE LOT #: 0062714, MEDICAL DEVICE EXPIRATION DATE: 02/28/2025, DEVICE MANUFACTURE DATE: 03/23/2020. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 10ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED LEAKAGE AND DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; LOTS# 0091899 OR 9301110 OR 0062714. JET OF WATER AND BLOOD COMING FROM THE SIDE OF THE SYRINGE DURING ITS USE DURING A STERILE PROCEDURE (RINSING OF THE FEMORAL THREAD 8F). 3 LOTS ARE POSSIBLE BUT PACKAGING ARE DISCARDED. WAS THERE ANY CONSEQUENCES FOR THE PATIENT? -NO. WAS THERE EXPOSURE TO BLOOD? -BLOOD SPILL IN THE DIRECTION OF THE CAREGIVER. THERE WAS CONTACT ON THE STERILE GOWN OF THE CAREGIVER. MEDICAL INTERVENTION OR CHANGE OF TREATMENT? -NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042489 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 300912 UNKNOWN 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other