BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALINE NORMAL 3ML PLASTIC TUBE

    MDR report key: 12155871 · Received July 12, 2021

    Report

    Report Number
    1119779-2021-01155
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    June 7, 2021
    Report Date
    March 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    PPM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: 2021-JUN-23 INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD REVIEW FOR BATCH 1072960 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND TORQUING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE MEDIA APPEARANCE. NO FOREIGN OBJECTS WERE OBSERVED IN QC SAMPLES AT THE TIME OF RELEASE. IF FOREIGN MATTER HAD BEEN NOTED DURING QC TESTING, THE PRODUCT WOULD HAVE BEEN PLACED ON QUALITY NOTIFICATION AND FURTHER ANALYSIS INCLUDING 100% INSPECTION OF THE BATCH WOULD HAVE BEEN CONDUCTED. COLOR AND CLARITY OF THIS PRODUCT IS ALSO EVALUATED PRIOR TO RELEASE TO ENSURE TO ENSURE THAT THEY CONFORM TO TYPICAL LEVELS. THE APPEARANCE OF THIS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. AS PART OF THE RELEASE CRITERIA FOR THIS PRODUCT, THE BHR IS REVIEWED TO CONFIRM THE FOLLOWING: THE TOTAL ELAPSED TIME BETWEEN END OF FORMULATION AND START OF THE AUTOCLAVE CYCLE WAS WITHIN THE SPECIFIED LIMITS. ALL AUTOCLAVE PARAMETERS CONFORMED TO THE VALIDATED CYCLE PARAMETERS FOR THIS PRODUCT. THE MINIMUM F0 FOR THIS PRODUCT WAS MET. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH PER CUSTOMER. RETENTION SAMPLES FROM BATCH 1072960 WERE AVAILABLE FOR INSPECTION. NO MEDIA DEFECTS WERE OBSERVED IN 10/10 RETENTION SAMPLES. THERE WERE 10/10 PROPERLY AFFIXED LABELS ONE LABEL PER TUBE. FOR INVESTIGATION OF FILL VOLUME ALL 10/10 TUBES WERE MEASURED USING A WATER BLANK TUBE WITH THE ACCEPTABLE FILL VOLUME. ALL 10/10 TUBES MEASURED AT THE ACCEPTABLE FILL VOLUME LEVEL. FOR FURTHER INVESTIGATION TWO RETENTIONS WERE TESTED ONE TUBE WAS PLACED AT 20-25 DEGREE CELSIUS AND ONE TUBE WAS PLACED AT 33¿37-DEGREE CELSIUS INCUBATION FOR A TOTAL OF SEVEN DAYS. BY THE SEVENTH DAY OF INCUBATION NO MICROBIAL GROWTH OR PARTICLES WERE OBSERVED IN EITHER TUBE. NO PHOTOS WERE RECEIVED FROM THIS BATCH TO ASSIST WITH THE INVESTIGATION FOR THIS BATCH. TWO RETURN TUBES WERE ALSO INCUBATED. ONE TUBE AT 20-25 DEGREE CELSIUS AND ONE TUBE AT 33-37 DEGREES CELSIUS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABEL WAS ILLEGIBLE WITH SALINE NORMAL 3ML PLASTIC TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) FOLDED/STAINED/WRINKLED LABELS.

    Additional Manufacturer Narrative · 1

    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 LABEL WAS ILLEGIBLE WITH SALINE NORMAL 3ML PLASTIC TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS). FOLDED/STAINED/WRINKLED LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052886 SALINE NORMAL 3ML PLASTIC TUBE REAGENT, GENERAL PURPOSE PPM BECTON, DICKINSON & CO. (SPARKS) 1072960

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown