BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 7801414 · Received August 21, 2018

    Report

    Report Number
    1710034-2018-00550
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 19, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826125
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: RECEIVED A TOTAL OF 55 UNITS AS FOLLOWS: 7132645 ¿ 36 UNITS, 6125672 ¿ 25 UNITS, 6292800 ¿ 18 UNITS, 7027892 ¿ 32 UNITS, 7076843 ¿ 32 UNITS, 7263928 ¿ 3 UNITS. COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE WITH LOT#: 7132645, 6125672, 6292800, 7027892, 7076843 AND 7263928 REGARDING ITEM#: 382644. DHR REVIEW OR JUSTIFICATION FOR OMISSION: 7132645, A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 22MAY17 24MAY17 AND PACKAGED ON PACKAGING LINE 10 FROM 27MAY17 THRU 28MAY17. 6125672, A TOTAL OF (B)(4) UNITS MANUFACTURED ON AFA LINE 10 FROM 6MAY16 THRU 8MAY16 AND PACKAGED ON PACKAGING LINE 10 FROM 9MAY16 THROUGH 10MAY16. (B)(4) FOR ¿BAD CUT¿ (PACKAGING) WAS INITIATED DURING PACKAGING PROCESS. BAD CUT IS ALONG THE LONG END OF THE PACKAGE AND IS UNRELATED TO THE DEFECT OF OPEN SEALS AT THE END OF THE UNIT PACKAGE. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO STANDARD OPERATING PROCEDURE. 6292800, A TOTAL OF (B)(4) WERE MANUFACTURED ON AFA LINE 10 FROM 21OCT16 THRU 23OCT16 AND PACKAGED ON PACKAGING LINE 10 ON 28OCT16. ONE NON-RELATED (B)(4), TIGHT COVERS) WAS INITIATED DURING PRODUCTION. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO STANDARD OPERATING PROCEDURE. 7027892, A TOTAL OF (B)(4) MANUFACTURED ON AFA LINE 10 FROM 28JAN17 THRU 1FEB17 AND PACKAGED ON PACKAGING LINE 10 FROM 2FEB17 THROUGH 3FEB17. 7076843, A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 21MAR17 THRU 23MAR17 AND PACKAGED ON PACKAGING LINE 10 FROM 25MAR17 THRU 26MAR17. 7263928, A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 26SEP17 THRU 27SEP17 AND PACKAGED ON PKG LINE 10 FROM 27SEP17 THROUGH 28SEP17. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL WIDTH WITH ADHESIVE TRANSFER FROM THE TOP WEB PAPER TO THE BOTTOM WEB FILM. THIS CHARACTERISTIC WAS MET. THE KEY VARIABLES THAT AFFECT THE SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. WATER-LEAK TEST: THE WATER LEAK TEST WAS PERFORMED ON ALL OF THE PACKAGES THAT WERE NOT OPEN, NO LEAKAGE WAS OBSERVED ON ANY OF THE AREAS OF THE PACKAGES TESTED. SUPPLIER OLIVER-TOLAS (OT) USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OT. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. CAPA: 48637 WAS INITIATED TO ADDRESS THE ISSUE OF OPEN SEAL COMPLAINTS. TASKS ASSOCIATED WITH THE CAPA PLAN HAVE BEEN COMPLETED. OTHER ACTIONS TAKEN: PACKAGING OPERATORS ARE RESPONSIBLE TO VERIFY PACKAGE INTEGRITY, INCLUDING THE VERIFICATION THAT THE PACKAGES ARE ADEQUATELY SEALED. IN ADDITION, PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING AND PACKAGING PROCESS WITH PRESCRIBED ATTRIBUTES INSPECTIONS. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PACKAGE OF A BD INSYTE¿ AUTOGUARD¿ WAS RECEIVED SLIGHTLY OPENED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7132645; MEDICAL DEVICE EXPIRATION DATE: 2020-04-30; DEVICE MANUFACTURE DATE: 2017-05-12. MEDICAL DEVICE LOT #: 6125672; MEDICAL DEVICE EXPIRATION DATE: 2019-04-30; DEVICE MANUFACTURE DATE: 2016-05-04. MEDICAL DEVICE LOT #: 6292800; MEDICAL DEVICE EXPIRATION DATE: 2019-09-30; DEVICE MANUFACTURE DATE: 2016-10-21. MEDICAL DEVICE LOT #: 7027892; MEDICAL DEVICE EXPIRATION DATE: 2019-12-31; DEVICE MANUFACTURE DATE: 2017-01-27. MEDICAL DEVICE LOT #: 7076843; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2017-03-20. MEDICAL DEVICE LOT #: 7263928; MEDICAL DEVICE EXPIRATION DATE: 2020-08-31; DEVICE MANUFACTURE DATE: 2017-09-20. 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 THE PACKAGE OF A BD INSYTE¿ AUTOGUARD¿ WAS RECEIVED SLIGHTLY OPENED BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641441 BD INSYTE¿ AUTOGUARD¿ INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903826125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other