BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 14469067 · Received May 23, 2022

    Report

    Report Number
    3003152976-2022-00228
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Date of Event
    April 29, 2022
    Report Date
    June 9, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THE NUMBERS IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2010065. D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2025. H4. DEVICE MANUFACTURE DATE: 16-OCT-2020. D4. MEDICAL DEVICE LOT #: 2002231. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025. H4. DEVICE MANUFACTURE DATE: 14-FEB-2020. D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 23-MAY-2022. H3. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGE IN THE BARREL WAS OBSERVED, THE DAMAGE CAUSING THE LEAK THAT WAS REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 2010065 AND 2002231, 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. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, BASED ON THE DAMAGE OBSERVED IT WAS DETERMINED THIS LIKELY OCCURRED DURING THE ASSEMBLY PROCESS. CAPA#4321210 WAS INITIATED TO FURTHER ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CRACK IN A BD PLASTIPAK¿ SYRINGE THAT CAUSED LEAKAGE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE DREW UP PROPOFOL AND THE FLUID LEAKED OUT IN THE PROCESS. THE LEAKAGE OCCURRED DURING PREPARATION (DRAWING UP OF PROPOFOL) AND THE TEAR WAS NOT VISIBLE TO THE EYE, THE TEAR WAS ONLY NOTICED WHEN THE DRUG CAME OUT. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CRACK IN A BD PLASTIPAK¿ SYRINGE THAT CAUSED LEAKAGE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE DREW UP PROPOFOL AND THE FLUID LEAKED OUT IN THE PROCESS. THE LEAKAGE OCCURRED DURING PREPARATION (DRAWING UP OF PROPOFOL) AND THE TEAR WAS NOT VISIBLE TO THE EYE, THE TEAR WAS ONLY NOTICED WHEN THE DRUG CAME OUT. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CRACK IN A BD PLASTIPAK¿ SYRINGE THAT CAUSED LEAKAGE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE DREW UP PROPOFOL AND THE FLUID LEAKED OUT IN THE PROCESS. THE LEAKAGE OCCURRED DURING PREPARATION (DRAWING UP OF PROPOFOL) AND THE TEAR WAS NOT VISIBLE TO THE EYE, THE TEAR WAS ONLY NOTICED WHEN THE DRUG CAME OUT. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368710 BD PLASTIPAK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown