BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALINE NORMAL 3ML PLASTIC TUBE 100 EA

    MDR report key: 12071705 · Received June 25, 2021

    Report

    Report Number
    1119779-2021-01062
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 21, 2021
    Report Date
    February 11, 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: D4: MEDICAL DEVICE LOT #: 1056378; D4: MEDICAL DEVICE EXPIRATION DATE: 2022-08-13; H4: DEVICE MANUFACTURE DATE: 2021-02-25. D4: MEDICAL DEVICE LOT #: 1042727; D4: MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; H4: DEVICE MANUFACTURE DATE: 2021-02-11. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-03. H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE FINDINGS REGARDING THE COMPLAINT RELATED TO, CATALOG NUMBER 215439, SALINE NORMAL 3ML PLASTIC TUBE 100EA, BATCH NUMBERS 1056378 AND 1042727. MATERIAL 215439 IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND THOROUGHLY MIXING UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE MEDIA IS DISPENSED INTO BOTTLES; CAPS ARE APPLIED MANUALLY THEN TORQUED BY MACHINE PER A STANDARD OPERATING PROCEDURE (SOP). THE BOTTLES ARE THEN LABELED AND TERMINALLY AUTOCLAVED IN AN AIR OVER PRESSURE (AOP) AUTOCLAVE, PER MANUFACTURING INSTRUCTIONS, USING A VALIDATED CYCLE. POST AUTOCLAVING, BOTTLES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1056378 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE APPEARANCE OF THIS BATCH WAS SATISFACTORY PER INTERNAL PROCEDURES. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1056378 (10 TUBES) WERE AVAILABLE FOR INSPECTION. ALL 10/10 RETENTION SAMPLES HAD ONE PROPERLY AFFIXED LABEL. NO PHOTOS WERE RECEIVED TO ASSIST FOR THIS BATCH WITH THIS INVESTIGATION. EIGHT TUBES WERE RETURNED WITH NO LABELS ON THE TUBE, AND NO PRODUCT VERIFICATION. THIS COMPLAINT CAN BE CONFIRMED BASED ON THE RETURNS. BD WILL CONTINUE TO TREND COMPLAINTS FOR LABELING. A TREND HAS NOT BEEN IDENTIFIED, THEREFORE, NO ACTIONS ARE PLANNED AT THIS TIME. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1042727 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, TORQUING, PACKAGING, AND AUTOCLAVING PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR ANY DEFECT BESIDES CUSTOMER. RETENTION SAMPLES FROM BATCH 1042727 (10 TUBES) WERE AVAILABLE FOR INSPECTION. THERE WERE NO LABELING DEFECTS, ALL 10/10 RETENTION SAMPLES HAD TEN PROPERLY AFFIXED LEGIBLE LABELS. NO PHOTOS FOR THIS BATCH WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED FOR THIS BATCH TO ASSIST WITH THE INVESTIGATION. THIS COMPLIANT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION, LABELING H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING SALINE NORMAL 3ML PLASTIC TUBE 100 EA MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER STATES APPROXIMATELY 8% OF THE TUBES HAVE BEEN REJECTED. CUSTOMER REPORTS THAT TUBES HAVE NO LABEL. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING SALINE NORMAL 3ML PLASTIC TUBE 100 EA MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES APPROXIMATELY 8% OF THE TUBES HAVE BEEN REJECTED. CUSTOMER REPORTS THAT TUBES HAVE NO LABEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968891 SALINE NORMAL 3ML PLASTIC TUBE 100 EA REAGENT, GENERAL PURPOSE PPM BECTON, DICKINSON & CO. (SPARKS) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown