BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8753065 · Received July 2, 2019

    Report

    Report Number
    3003152976-2019-00437
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 17, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1904228, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1904228 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS LEAKAGE PAST THE STOPPER WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: LEAKAGE OBSERVED ON THE STOPPER OF 2 SYRINGES OF 50ML 3P LUER LOCK BD PLASTIPAK LOT 1904228. PROVEN CONSEQUENCES: CYTARABINE LEAKAGE OUTSIDE THE SYRINGE THE AFFECTED SYRINGES WERE NOT RETAINED FOR ANALYSIS. ADDITIONAL INFORMATION FROM THE CUSTOMER: SERIOUS INJURY? NO. ERRONEOUS RESULTS? NO. COURSE OF TREATMENT CHANGED? NO CHANGE IN TREATMENT, BUT THEY NEEDED TO PROVIDE NEW SYRINGE, SO WASTE OF TIME AND PRODUCTS. EXPOSURE TO BLOOD/BODILY FLUID? NO BUT THERE WAS A RISK (NOT RISK OF EXPOSURE TO BLOOD, BUT RISK OF EXPOSURE TO CYTARABINE FOR THE CAREGIVER IF WE HAD NOT SEEN THE LEAK AND WE HAD SENT THE SYRINGE IN THE SERVICE). MEDICAL INTERVENTION? NO. OTHER ACTIONS? NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAKAGE PAST THE STOPPER WITH A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE. THIS OCCURRED ON 2 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: LEAKAGE OBSERVED ON THE STOPPER OF 2 SYRINGES OF 50ML 3P LUER LOCK BD PLASTIPAK LOT 1904228. PROVEN CONSEQUENCES: CYTARABINE LEAKAGE OUTSIDE THE SYRINGE. THE AFFECTED SYRINGES WERE NOT RETAINED FOR ANALYSIS. ADDITIONAL INFORMATION FROM THE CUSTOMER: SERIOUS INJURY? NO. ERRONEOUS RESULTS? NO. COURSE OF TREATMENT CHANGED? NO CHANGE IN TREATMENT, BUT THEY NEEDED TO PROVIDE NEW SYRINGE, SO WASTE OF TIME AND PRODUCTS. EXPOSURE TO BLOOD/BODILY FLUID? NO BUT THERE WAS A RISK (NOT RISK OF EXPOSURE TO BLOOD, BUT RISK OF EXPOSURE TO CYTARABINE FOR THE CAREGIVER IF WE HAD NOT SEEN THE LEAK AND WE HAD SENT THE SYRINGE IN THE SERVICE). MEDICAL INTERVENTION? NO. OTHER ACTIONS? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550096 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1904228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other