BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 10180535 · Received June 22, 2020

    Report

    Report Number
    9616657-2020-00095
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 29, 2020
    Report Date
    June 22, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0035110 AND 0111366 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS NO PHYSICAL SAMPLES OR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, OUR QUALITY TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE INVESTIGATION. A FIELD SAFETY NOTICE HAS BEEN COMMUNICATED RELATED TO THIS POTENTIAL DEFECT; HOWEVER, THE LOT NUMBERS REFERENCED IN THIS COMPLAINT ARE NOT A PART OF THE NOTICE. BOTH LOT NUMBERS REPORTED IN THIS INCIDENT WERE MANUFACTURED ON A SEPARATE PRODUCTION LINE THAN THE LOT NUMBERS AFFECTED IN THE FIELD SAFETY NOTICE. BASED ON THE INVESTIGATION RESULTS, NO ISSUES WITH THE REPORTED PRODUCTS COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED POOR SEALS ON PACKAGING PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTACTED TO ADVISE ALL THE SALINE PRE FILLED SYRINGES ARE FROM THE AFFECTED BATCH. SOME HAVE HOLES IN BUT CUSTOMER IS CONCERNED THERE MAY BE UNDETECTED SMALL HOLES IN OTHERS SO NOT HAPPY TO USE ANY.

    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 #: 0111366, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31, DEVICE MANUFACTURE DATE: 2020-04-20, MEDICAL DEVICE LOT #: 0035110, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2020-02-04, 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 AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED POOR SEALS ON PACKAGING PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONTACTED TO ADVISE ALL THE SALINE PRE FILLED SYRINGES ARE FROM THE AFFECTED BATCH. SOME HAVE HOLES IN BUT CUSTOMER IS CONCERNED THERE MAY BE UNDETECTED SMALL HOLES IN OTHERS SO NOT HAPPY TO USE ANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641630 BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% PREFILLED SALINE SYRINGE NGT BECTON, DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other