BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10448155 · Received August 25, 2020

    Report

    Report Number
    3003152976-2020-00385
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 4, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    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: 2020-08-19. H.6. INVESTIGATION SUMMARY ONE UNUSED SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD NOT BE OBSERVED THAT THE SCALE WAS INCORRECTLY PLACED ON THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003233, 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. DURING THE BARREL PRINTING PROCESS, OPERATORS PERIODICALLY VERIFY THE VOLUME ACCURACY WITH A PASS/NON PASS GAUGE. THE RETURNED SAMPLE WAS EVALUATED USING THE SAME METHOD AND WERE FOUND TO BE WITHIN REQUIRED TOLERANCE. SCALE PRECISION AND DIED SPACE IS ALSO INSPECTED DURING MANUFACTURING AND PRODUCT WAS FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VOLUMETRIC ACCURACY ISSUES, A 50ML ACTUALLY CONTAINED 51ML OF MEDICATION DURING USE WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE USE 50ML PLASTIPAK SYRINGES REFERENCE 300865 TO CHEMOTHERAPY. FOR 10 DAYS, OUR PREPARERS HAVE OBSERVED THAT THE LEFTOVERS FROM THEIR BOTTLES ARE FAKE AND THAT THE BOTTLES EMPTY FASTER THAN EXPECTED. THEY TESTED THE SYRINGE: THEY COLLECTED 50ML OF PHY SERUM FROM THE BD SYRINGE AND TRANSFERRED THE CONTENTS TO A TEST TUBE THAT INDICATED 51ML. THEY REPEATED THIS OPERATION SEVERAL TIMES WITH SEVERAL SYRINGES, WITH ALWAYS ONE DIFFERENCE OBSERVED. OUR PREPARERS HAVE BEEN USING THESE SYRINGES ON THE CHEMOTHERAPY STATION FOR A LONG TIME AND HAVE ONLY OBSERVED THIS PROBLEM FOR ABOUT 10 DAYS. STOPPING THE USE OF BD SYRINGES BY OUR CHEMOTHERAPY UNIT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOLUMETRIC ACCURACY ISSUES, A 50 ML ACTUALLY CONTAINED 51 ML OF MEDICATION DURING USE WITH A BD PLASTIPAK¿ 50 ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE USE 50 ML PLASTIPAK SYRINGES REFERENCE 300865 TO CHEMOTHERAPY. FOR 10 DAYS, OUR PREPARERS HAVE OBSERVED THAT THE LEFTOVERS FROM THEIR BOTTLES ARE FAKE AND THAT THE BOTTLES EMPTY FASTER THAN EXPECTED. THEY TESTED THE SYRINGE: THEY COLLECTED 50 ML OF PHY SERUM FROM THE BD SYRINGE AND TRANSFERRED THE CONTENTS TO A TEST TUBE THAT INDICATED 51 ML. THEY REPEATED THIS OPERATION SEVERAL TIMES WITH SEVERAL SYRINGES, WITH ALWAYS ONE DIFFERENCE OBSERVED. OUR PREPARERS HAVE BEEN USING THESE SYRINGES ON THE CHEMOTHERAPY STATION FOR A LONG TIME AND HAVE ONLY OBSERVED THIS PROBLEM FOR ABOUT 10 DAYS. STOPPING THE USE OF BD SYRINGES BY OUR CHEMOTHERAPY UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916573 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003233

    Patients

    Seq Age Sex Outcome Treatment
    1 Other