BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGES

    MDR report key: 16577479 · Received March 20, 2023

    Report

    Report Number
    3003152976-2023-00080
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 28, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 21-MAR-2023. INVESTIGATION SUMMARY: TWO SAMPLES RECEIVED FOR INVESTIGATION FOR BATCH NUMBERS 2205801 AND 2209081. UPON VISUAL EVALUATION, NO DEFECTS OR ISSUES OBSERVED. SYRINGES WERE DISASSEMBLED TO EXAMINE PARTS SEPARATELY. NO DEFECTS WERE DETECTED IN PARTS BY SEPARATE AND NO MOLDING DEFECTS WERE IDENTIFIED. STOPPER WERE CORRECTLY ASSEMBLED IN ALL THE SYRINGES. NO SAMPLES OR PHOTOS RECEIVED FOR BATCH NUMBER REPORTED 2211096, THEREFORE THE INCIDENT IS NOT CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2211096, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE INVESTIGATION RESULTS, WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THIS INCIDENT OCCURRED DUE TO UNEVEN DISTRIBUTION OF SILICONE INSIDE THE BARREL.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE ALARMING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: WHEN IT IS NECESSARY TO USE THE ABOVE SYRINGES AND SET THEM IN THE RIGHT WAY (ADEQUATE TO THE SYRINGE USED) THE PUMP ALERTS WHEN THERE IS STILL ABOUT 8- 10 ML OF DRUG, THE PUMP SIGNALS THE END AND KVO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE ALARMING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM POLISH TO ENGLISH: WHEN IT IS NECESSARY TO USE THE ABOVE SYRINGES AND SET THEM IN THE RIGHT WAY (ADEQUATE TO THE SYRINGE USED) THE PUMP ALERTS WHEN THERE IS STILL ABOUT 8- 10 ML OF DRUG, THE PUMP SIGNALS THE END AND KVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355095 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown