BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD

    MDR report key: 8947018 · Received August 29, 2019

    Report

    Report Number
    1710034-2019-00947
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    July 31, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. CONCLUSION(S): A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE WITH LOT #7152643 REGARDING ITEM #381933. RELATED: 1110583 1104963 1104934 IF YES, PROVIDE DHR REVIEW OR JUSTIFICATION FOR OMISSION: DHR REVIEW WAS PERFORMED ON LOT NUMBER 71542643; THE LOT NUMBER WAS BUILT ON AFA LINE 6 ON 04JUN2018 PACKAGED ON PACKAGING LINE 10 ON 06JUN2017 FOR A QUANTITY OF (B)(4) UNITS.REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS.REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS ON THE BUILD ON THIS LOT NUMBER. ANALYSIS OF PEURA AND/OR FMEA CONDUCTED BY QE: FINDINGS: RM5835 REV 16 VERSION N WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. RM5835 IDENTIFIES THE FAILURE MODE OF BREACH IN PACKAGE INTEGRITY AS A REMOTE OCCURRENCE (FEWER THAN 10.0 INCIDENTS PER MILLION UNITS) AND LIMITED SEVERITY DUE TO LOCALIZED INFECTION AND AS A FREQUENT OCCURRENCE (MORE THAN 1000 INCIDENTS PER MILLION UNITS) AND NEGLIGIBLE SEVERITY DUE TO CLINICIAN DISSATISFACTION. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. CONCLUSION(S): NO PHYSICAL SAMPLES WERE NOT RECEIVED FOR TESTING AND EVALUATION; ONE PHOTO WAS SUBMITTED FOR EVALUATION OF THIS INCIDENT. THE PHOTO DISPLAYED THREE PACKAGES; ONE PACKAGE WITH THE BOTTOM OF THE BLISTER PACK PARTIALLY OPENED, SIDE OF THE BLISTER PACKAGE WAS PARTIALLY OPENED AND PACKAGE WITH PRODUCT IN IT. PROVIDE RESULTS, ANY TESTING PERFORMED, AND OTHER RELEVANT INFORMATION CONCLUSION(S): THE PHOTO SUBMITTED FOR REVIEW DISPLAYED A PACKAGE WITH BOTTOM OF THE BLISTER PACK AND SIDE OF THE BLISTER PACK PARTIALLY OPENED. *NOTE: THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE SEAL TRANSFER/WIDTH AND PAPER TOP WEB GLUE. BECAUSE ONLY THE PHOTO WAS SUBMITTED FOR EVALUATION, THESE CHARACTERISTICS COULD NOT BE INVESTIGATED.7. PROBABLE ROOT CAUSE CONCLUSION(S): BD SUPPLIER OLIVER-TOLAS (OT) 29LP USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE.8. ACTIONS TAKEN IF NO ACTIONS PROVIDE JUSTIFICATION IN THE CONCLUSION BELOW.CONCLUSION(S): CAPA 48637 WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PACKAGE SEAL INTEGRITY WAS FOUND BEFORE USE WITH A 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LOSS OF INTEGRITY FOR THE PACKAGE."

    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 PACKAGE SEAL INTEGRITY WAS FOUND BEFORE USE WITH A 20G X 1.00 IN (1.1 X 25 MM) INSYTE AUTOGUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LOSS OF INTEGRITY FOR THE PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742059 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7152643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other