BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOGUARD CATHETERS

    MDR report key: 8124766 · Received December 3, 2018

    Report

    Report Number
    1710034-2018-00887
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 14, 2018
    Report Date
    January 25, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 AND H.1 WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: D.4 MEDICAL DEVICE EXPIRATION DATE. H.4 DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    CATALOG #, LOT #, MEDICAL DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, AND UDI # WERE UPDATED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6008778, MEDICAL DEVICE EXPIRATION DATE: 2018-12-31, DEVICE MANUFACTURE DATE: 2016-01-08. MEDICAL DEVICE LOT #: 7030912, MEDICAL DEVICE EXPIRATION DATE: 2020-01-31, DEVICE MANUFACTURE DATE: 2017-02-06.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED TWO 22GA INSYTE AUTOGUARD UNITS WITHIN PARTIALLY OPENED PACKAGES FROM LOT 6008778. ALL COMPONENTS WERE PRESENT AND INTACT WITHIN THE BLISTER PACKS WHICH WERE PARTIALLY OPENED AT THE TOP AND BOTTOM ENDS. A 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 #6008778 AND 7030912 REGARDING ITEM #381823. DHR REVIEWS; WERE CONDUCTED FOR THIS INVESTIGATION WHICH DISCLOSED THE FOLLOWING: LOT 6008778; WAS MANUFACTURED ON AFA LINE 5 ON 21JAN2016 THROUGH 26JAN2016 AND PACKAGED ON PKG. LINE 9 FROM 25JAN2016 THROUGH 27JAN2016 FOR THE QUANTITY OF (B)(4) EA. ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES AND TESTING WERE PERFORMED IN ACCORDANCE PER THE QUALITY CONTROL PLANS. THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT, THEREFORE THERE WERE NO INDICATIONS OF THE ALLEGED DEFECT. THERE WAS THREE NON-RELATED TEMPORARY DEVIATIONS IN EFFECT DURING THE BUILD OF THIS LOT. LOT 7030912; WAS MANUFACTURED ON AFA LINE 5 ON 08FEB2017 THROUGH 12FEB2017AND PACKAGED ON PKG. LINE 8 FROM 11FEB2017 THROUGH 13FEB2017 FOR THE QUANTITY OF (B)(4) EA. ALL CHALLENGE, SET UP AND IN PROCESS SAMPLES AND TESTING WERE PERFORMED IN ACCORDANCE PER THE QUALITY CONTROL PLANS. THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT, THEREFORE THERE WERE NO INDICATIONS OF THE ALLEGED DEFECT. SAP (QN) DATABASE REVIEW WAS CONDUCTED FOR THIS INVESTIGATION WHICH DISCLOSED THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECT ASSOCIATED WITH THE LOT NUMBERS PROVIDED FOR THIS INCIDENT, AS NO QNS WERE INITIATED FOR THESE LOTS. INVESTIGATION CONCLUSION: VISUAL/MICROSCOPIC EXAMINATION OBSERVED THAT ALTHOUGH THE UNIT PACKAGES HAD THE PARTIALLY OPEN SEAL AT THE TOP AND BOTTOM OF THE BLISTER PACKS AND THE STERILITY BARRIER WAS COMPROMISED AT BOTH ENDS; THE UNIT PACKAGES (BLISTER PACKS) DEMONSTRATED TO HAVE HAD AN ADEQUATE SEAL WITH NO ANOMALIES AT TIME OF MANUFACTURING. THE PRODUCT CHARACTERISTICS REQUIRE A MINIMUM OF 1/8¿ SEAL TRANSFER. THIS CHARACTERISTIC WAS MET AND THE ANALYSIS REVEALED ADEQUATE TOP WEB ADHESIVE. THE KEY VARIABLES THAT AFFECT SEAL STRENGTH ARE: SEAL TRANSFER/WIDTH AND TOP WEB GLUE. BOTH OF THESE VARIABLES WERE INCLUDED (CONFIRMED) IN THE INVESTIGATION. ROOT CAUSE DESCRIPTION: 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. RATIONALE: THIS PACKAGING ISSUE IS UNDER INVESTIGATION: CAPA 48637 WAS OPENED TO ADDRESS THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD CATHETERS HAD STERILITY BREACH BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD CATHETERS HAD STERILITY BREACH BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ INSYTE AUTOGUARD CATHETERS HAD STERILITY BREACH BEFORE USE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. 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¿ INSYTE AUTOGUARD CATHETERS HAD STERILITY BREACH BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964288 BD¿ INSYTE AUTOGUARD CATHETERS INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other