BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8126790 · Received December 3, 2018

    Report

    Report Number
    1710034-2018-00886
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 14, 2018
    Report Date
    January 22, 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
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 6154521: THE LOT NUMBER WAS BUILT ON AFA LINE 8, FROM 7JUN16 THROUGH 12JUN16 FOR THE AMOUNT OF 261,210EA. PACKAGED ON PKG LINE 9 FROM 12JUN16 THROUGH 13JUN16. ALL CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. NO QUALITY NOTIFICATIONS WERE INITIATED DURING PRODUCTION. 6243756: THE LOT NUMBER WAS BUILT ON AFA LINE 8, FROM 3SEP16 THROUGH 10SEP16 FOR THE AMOUNT OF 444,810EA. PACKAGED ON PKG LINE 11 FROM 7SEP16 THROUGH 11SEP16. ALL CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. NO QUALITY NOTIFICATIONS WERE INITIATED DURING PRODUCTION. 7121757: THE LOT NUMBER WAS BUILT ON AFA LINE 8, FROM 4MAY17 THROUGH 8MAY17 FOR THE AMOUNT OF 262,010EA. PACKAGED ON PKG LINE 11 FROM 7MAY17 THROUGH 8MAY17. ALL CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. NO QUALITY NOTIFICATIONS WERE INITIATED DURING PRODUCTION. ONE NON-RELATED TD WAS IN PLACE DURING PRODUCTION (2017-37 PM SCHEDULE CHANGE). RECEIVED A TOTAL OF 3 IAG UNITS ONE UNIT FROM EACH OF THE LOT (6154521, 6243756 AND 7121757) ALL COMPONENTS WITHIN WERE PRESENT AND INTACT. ALL UNITS RECEIVED WERE PARTIALLY OPEN AT BOTH ENDS 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 OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. CONCLUSION(S): SUPPLIER ¿ DEFECTIVE MATERIAL 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. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: IT WAS REPORTED WITH THE USE OF THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH. MEDICAL DEVICE BRAND NAME: BD INSYTE AUTOGUARD SHIELDED IV CATHETER. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6154521, MEDICAL DEVICE EXPIRATION DATE: 2019-05-31, DEVICE MANUFACTURE DATE: 2016-06-02. MEDICAL DEVICE LOT #: 6243756, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31, DEVICE MANUFACTURE DATE: 2016-09-02. MEDICAL DEVICE LOT #: 7121757, MEDICAL DEVICE EXPIRATION DATE: 2020-04-30, DEVICE MANUFACTURE DATE: 2017-05-03. PMA/510(K)#: K952861.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ CATHETER THERE WAS AN ISSUE WITH STERILE BREACH.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE AUTOGUARD SHIELDED IV CATHETER THERE WAS AN ISSUE WITH STERILE BREACH.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ CATHETER THERE WAS AN ISSUE WITH STERILE BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966025 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other