BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 11208426 · Received January 21, 2021

    Report

    Report Number
    9616657-2021-00010
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    November 4, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/16/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0223146 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION, FIVE PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, FOREIGN MATTER AND DAMAGE TO THE PRODUCT PACKAGING WAS OBSERVED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM JAMS IN THE MULTIVAC MACHINERY, WHICH CAUSED CONTAMINATION IN THE TRIM CATCHING CHAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 61 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY RECEIVED REPEATED MESSAGES FROM OUR PACKAGING DEPARTMENT THAT THE PACKAGES OF BD POSIFLUSH ART. NO. 306572 ARE TORN, DAMAGED AND PARTIALLY DIRTY (INSIDE). AT THE MOMENT WE HAVE 61 PIECES, BATCH 0223146 FROM OUR PACKAGING RECEIVED BACK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE ORIGINAL COMPLAINT INFORMATION DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE BRAND NAME: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%. INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FAX #: (B)(6). (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0223146 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION, FIVE PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, DAMAGE TO THE PRODUCT PACKAGING WAS OBSERVED. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM JAMS IN THE MULTIVAC MACHINERY, WHICH CAUSED CONTAMINATION IN THE TRIM CATCHING CHAIN. THIS ISSUE HAS BEEN IDENTIFIED AND RESOLVED BY THE MANUFACTURING TEAM TO PREVENT FURTHER DEFECTS. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION, IT IS POSSIBLE THE PACKAGE DAMAGE MAY BE RELATED TO TRIM JAMS ON THE MULTIVAC WHICH MAY HAVE CAUSED CONTAMINATION FROM THE TRIM CATCHING THE CHAIN. THE ISSUE WAS IDENTIFIED AND RESOLVED AT THE TIME OF OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 61 BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECENTLY RECEIVED REPEATED MESSAGES FROM OUR PACKAGING DEPARTMENT THAT THE PACKAGES OF BD POSIFLUSH ART. NO. 306572 ARE TORN, DAMAGED AND PARTIALLY DIRTY (INSIDE). AT THE MOMENT WE HAVE 61 PIECES, BATCH 0223146 FROM OUR PACKAGING RECEIVED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104194 SEE H10 SALINE FLUSH SYRINGE NGT BECTON, DICKINSON AND CO. 0223146

    Patients

    Seq Age Sex Outcome Treatment
    1