BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 8191305 · Received December 21, 2018

    Report

    Report Number
    1710034-2018-00920
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 17, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH. THERE WERE 4 DEVICES AFFECTED BY THIS MALFUNCTION. H.6. INVESTIGATION SUMMARY: DHR REVIEW WAS PERFORMED ON LOT NUMBERS 7237905; THE LOT NUMBER WAS BUILT ON AFA LINE 2 FROM 30AUH17 THRU 04SEPT17. PACKAGED ON PACKAGING LINE 8 FROM (PALLETS 1-12) 03SEPT17 THRU 06SEPT17 AND (PALLETS 13-15) 11JAN18 THRU 11JAN18. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED ONE NON-RELATED QNS WERE INITIATED DURING THE BUILD OF THIS LOT THAT WOULD NOT IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. 7110801: THE LOT NUMBER WAS MANUFACTURE ON AFA LINE 5 FROM 25APR17 THRU 30APR17. PACKAGED ON PACKAGING LINE 11 FROM 30APR17 THRU 02MAY17. 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 THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. NO QUALITY NOTIFICATION WERE INITIATED DURING THE BUILD OF THIS LOT NUMBER. RECEIVED THREE IAG 22GA UNITS FROM LOT NUMBER 7237905 AND ONE IAG 22GA UNIT FROM LOT NUMBER 7110801. PACKAGE WAS PARTIALLY OPENED, BUT THIS IS THE BASIS OF THE COMPLAINT. VISUAL/MICROSCOPIC EVALUATION: 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 PACKAGING SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH VARIABLES WERE INCLUDED IN THE INVESTIGATION. THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNITS THAT WAS PARTIALLY OPEN AT THE TOP AND BOTTOM OF THE BLISTER PACK. EVEN THOUGH THE PACKAGES WERE RECEIVED PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. BD SUPPLIER (B)(4) (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. DUE TO CONTINUOUS ISSUES WITH OT, BD IS MOVING TO AN ALTERNATE SUPPLIER FOR THE TOP WEB MATERIAL. 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 BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH. THERE WERE 4 DEVICES AFFECTED BY THIS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7237905. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2017-08-25. MEDICAL DEVICE LOT #: 7110801. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2017-04-20. (B)(6). 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 BD¿ NSYTE AUTOGUARD SHIELDED IV CATHETER HAD STERILITY BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031788 BD¿ NSYTE AUTOGUARD SHIELDED IV CATHETER PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other