BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7280876 · Received February 19, 2018

    Report

    Report Number
    1710034-2018-00057
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    February 3, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814542
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE LOT NUMBER(S), DEVICE MANUFACTURING DATE(S), AND DEVICE EXPIRATION DATE(S). THE FOLLOWING FIELD(S) HAVE BEEN UPDATED: MEDICAL DEVICE LOT #: 3360773. MEDICAL DEVICE EXPIRATION DATE: 2017-01-31. DEVICE MANUFACTURE DATE: 2013-12-26. MEDICAL DEVICE LOT #: 4086979. MEDICAL DEVICE EXPIRATION DATE: 2017-03-31. DEVICE MANUFACTURE DATE: 2014-03-27. MEDICAL DEVICE LOT #: 4293835. MEDICAL DEVICE EXPIRATION DATE: 2017-10-31. DEVICE MANUFACTURE DATE: 2014-10-20. MEDICAL DEVICE LOT #: 5019881. MEDICAL DEVICE EXPIRATION DATE: 2018-01-31. DEVICE MANUFACTURE DATE: 2015-01-19. MEDICAL DEVICE LOT #: 5086952. MEDICAL DEVICE EXPIRATION DATE: 2018-03-31. DEVICE MANUFACTURE DATE: 2015-03-27. MEDICAL DEVICE LOT #: 5114511. MEDICAL DEVICE EXPIRATION DATE: 2018-04-30. DEVICE MANUFACTURE DATE: 2015-04-24. MEDICAL DEVICE LOT #: 5163676. MEDICAL DEVICE EXPIRATION DATE:2018-05-31. DEVICE MANUFACTURE DATE: 2015-06-12. MEDICAL DEVICE LOT #: 5225980. MEDICAL DEVICE EXPIRATION DATE: 2018-07-31. DEVICE MANUFACTURE DATE: 2015-08-13. MEDICAL DEVICE LOT #: 5363668. MEDICAL DEVICE EXPIRATION DATE: 2018-12-31. DEVICE MANUFACTURE DATE: 2015-12-29. MEDICAL DEVICE LOT #: 5300850. MEDICAL DEVICE EXPIRATION DATE: 2018-09-30. DEVICE MANUFACTURE DATE: 2015-10-28. MEDICAL DEVICE LOT #: 6118681. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31 . DEVICE MANUFACTURE DATE: 2016-04-27. MEDICAL DEVICE LOT #: 6215554. MEDICAL DEVICE EXPIRATION DATE: 2019-07-31. DEVICE MANUFACTURE DATE: 2016-08-03. MEDICAL DEVICE LOT #: 6224626. MEDICAL DEVICE EXPIRATION DATE: 2019-07-31. DEVICE MANUFACTURE DATE: 2016-08-11. MEDICAL DEVICE LOT #: 7082952. MEDICAL DEVICE EXPIRATION DATE: 2020-02-29. DEVICE MANUFACTURE DATE: 2017-03-27.

    Additional Manufacturer Narrative · 0

    BD RECEIVED PICTURE SAMPLES FOR EVALUATION. UPON EXAMINATION, THE PACKAGES WERE OBSERVED PARTIALLY OPEN. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FROM THE PROVIDED PICTURES, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. LOT ANALYSIS DEVICE/BATCH HISTORY RECORD REVIEW: YES REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: AS THIS COMPLAINT WAS A MDR; -DHR REVIEW WAS PERFORMED ON THE FOLLOWING LOT NUMBERS: 6302755 ¿ THE LOT NUMBER WAS PACKAGED ON PACKAGING LINE 11 FROM NOVEMBER 4, 2016 THRU NOVEMBER 9, 2016 AND DECEMBER 2, 2016 THRU DECEMBER 2, 2016. THE REVIEW OF THE DHR¿S IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SET-UP AND IN PROCESS SAMPLES (INCLUDED BUT NOT LIMITED) BLISTER THICKNESS, BAD SEAL/CUT/HOLES, SEAL TRANSFER WIDTH AND PACKAGE LEAK TEST WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. QN / SAP DATABASE REVIEW: NO. REASON: A REVIEW OF THE QN/SAP DATABASE IS NOT REQUIRED FOR A S1 ¿ O1 LEVEL A INVESTIGATION PER (B)(4). VISUAL ANALYSIS. OBSERVATIONS: ALTHOUGH OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE A SAMPLE WAS NOT RECEIVED FOR INVESTIGATION, THERE WERE TWO PHOTOS SUBMITTED THAT WERE REVIEWED. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. PER OBSERVATION OF THE PHOTOS PROVIDED THIS CHARACTERISTIC WAS MET. IN ADDITION, THE BOTTOM WEB IN THE PHOTOS REVEALED EVIDENCE OF ADEQUATE TRANSFER (ADHESIVE) FROM THE PAPER TOP WEB AT THE OPEN SEALS AND PARTIALLY OPEN SEALS OF THE PACKAGES (BLISTER PACKS). THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. BOTH VARIABLES WERE INCLUDED IN THE OBSERVATIONS INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: YES: ALTHOUGH THE PACKAGES WERE PARTIALLY OPEN AT THE TOP; THE PHOTOS EVALUATED FOR THIS INCIDENT REVEALED THE UNITS TO BE ACCEPTABLE PER THE MANUFACTURING SPECIFICATION REQUIREMENTS. CONCLUSIONS: THE DEFECT PACKAGE DAMAGE/DEFECTIVE/OTHER, AS STATED AS THE REPORTED CODE WAS CONFIRMED BASED ON THE EVALUATION OF THE PROVIDED PHOTOS. EVEN THOUGH THE PACKAGES CAME PARTIALLY OPENED, ALL THE PROCESSES CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL STRENGTH WERE OBSERVED TO BE WITHIN SPECIFICATION. INVESTIGATION CONCLUSION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE COMMENT: ALTHOUGH THE PACKAGES WERE OBSERVED TO BE PARTIALLY OPENED, THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT. (B)(4) HAS BEEN OPENED TO INVESTIGATE THE PACKAGE OPEN SEAL DEFECTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER ¿THAT THE PACKAGES WERE PREMATURELY OPENING.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124742 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903814542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other