BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10047508 · Received May 12, 2020

    Report

    Report Number
    3003152976-2020-00194
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 21, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2001235, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2001235 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. BASED ON QDA LIMITS FOR THIS PRODUCT AND DEFECT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN DRAWING MEDICATION, LEAKAGE OCCURRED BEHIND THE PLUNGER WITH A BD PLASTIPAK¿ 50 ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN DRAWING FARMORUBINE, A PINK COLOUR (FARMO) WAS VISIBLE BEHIND THE PLUNGER OF A 50 ML SYRINGE OF LOT 2001235. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: DID THE DEFECT LEAD TO SERIOUS INJURY? NO. DID THE TREATMENT PLAN HAVE TO BE ADJUSTED AS A RESULT OF THIS INCIDENT? NO (INCIDENT OCCURRED DURING PREPARATION OF CYTOSTATICS). WAS THERE ANY MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT? NO. OTHER ACTIONS THAT NEEDED TO BE TAKEN? MEASURES TO DEAL WITH CYTOSTATIC SPILLS. COULD YOU CONFIRM IF YOU STILL HAVE THE UNUSED SAMPLES AT YOUR DISPOSAL? IF SO, COULD YOU PROVIDE THE ADDRESS WHERE THE SAMPLES CAN BE COLLECTED? WE WOULD LIKE TO HAVE THEM COLLECTED. WE WOULD ALSO NEED THE TELEPHONE NUMBER OF THE CONTACT PERSON. THE SYRINGE HAS NOT BEEN RETAINED AS IT IS A TOXIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509867 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other