BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE LUER-LOK

    MDR report key: 8610041 · Received May 14, 2019

    Report

    Report Number
    3003152976-2019-00321
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 26, 2019
    Report Date
    June 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH INSPECTION OF THE PHOTO, THE PLUNGER IS OBSERVED TO BE BROKEN. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SUSPECTED LOTS 1810252, 1901249 AND 1812241. RETAINED SAMPLES OF EACH POTENTIAL LOT WERE USED FOR FURTHER EVALUATION. THE PRODUCT WAS INSPECTED AND FOUND NO DAMAGE OR MOLDING DEFECT IN ANY OF THE PRODUCT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER SNAPPED DURING THE FLUSH. LOT #'S 1810252, AND 1901249, AND 1812241 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE PLUNGER SNAPPED WHEN FLUSHING. NO ISSUE WITH THE LINE THAT WAS IN THE PATIENT (IE WAS NOT PUSHING THE SYRINGE PLUNGER HARD. DOCTOR ALSO DOUBLE CHECKED THAT HE DIDN'T DO SOMETHING WRONG I.E THAT IT WAS USER ERROR. WAS ABLE TO INSERT CONTRAST INTO THE LINE NORMALLY WITH THREE OTHER SYRINGES AFTER THE FACT. UNABLE TO ESTABLISH EXACT LOT NUMBER BUT THE THREE LOTS ON THE COMPLAINT WERE THE ONES PRESENT IN THE THEATRE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1810252, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2018-10-19. MEDICAL DEVICE LOT #: 1901249, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-14. MEDICAL DEVICE LOT #: 1812241, MEDICAL DEVICE EXPIRATION DATE: 2023-11-30, DEVICE MANUFACTURE DATE: 2018-12-10. 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 THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PLUNGER SNAPPED DURING THE FLUSH. LOT #'S 1810252, AND 1901249, AND 1812241 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE PLUNGER SNAPPED WHEN FLUSHING. NO ISSUE WITH THE LINE THAT WAS IN THE PATIENT (IE WAS NOT PUSHING THE SYRINGE PLUNGER HARD. DOCTOR ALSO DOUBLE CHECKED THAT HE DIDN'T DO SOMETHING WRONG I.E THAT IT WAS USER ERROR. WAS ABLE TO INSERT CONTRAST INTO THE LINE NORMALLY WITH THREE OTHER SYRINGES AFTER THE FACT. UNABLE TO ESTABLISH EXACT LOT NUMBER BUT THE THREE LOTS ON THE COMPLAINT WERE THE ONES PRESENT IN THE THEATRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403496 BD PLASTIPAK SYRINGE LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other