BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7798670 · Received August 20, 2018

    Report

    Report Number
    1710034-2018-00556
    Event Type
    Malfunction
    Date Received
    August 20, 2018
    Date of Event
    July 31, 2018
    Report Date
    October 9, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826446
    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

    INVESTIGATION SUMMARY: DHR REVIEWS 7165943-A TOTAL OF 165,010 UNITS WERE MANUFACTURED ON AFA LINE 9 FROM JUNE 16, 2017 THRU JUNE 19, 2017 AND PACKAGED ON LINE 10 FROM JUNE 20, 2017 THROUGH JUNE 21, 2017. 6176525- A TOTAL OF 129,810 UNITS WERE MANUFACTURED ON AFA LINE 6 FROM JUNE 27, 2016 THRU JUNE 30, 2016 AND PACKAGED ON PACKAGING LINE 10 FROM JULY 1, 2016 THRU JULY 2, 2016. 6342579- A TOTAL OF 111,410 UNITS WERE MANUFACTURED ON AFA LINE 9 FROM DEC 12, 2016 THRU DEC 13, 2016 AND PACKAGED ON PKG LINE 10 ON DEC 13, 2016 7031848- A TOTAL OF 148,210 UNITS WERE MANUFACTURED ON AFA LINE 9 FROM FEB 8, 2017 THRU FEB 10, 2017 AND PACKAGED ON PACKAGING LINE 10 FROM FEB 11, 2017 THRU FEB 12, 2017 7097656- A TOTAL OF 91,410 UNITS WERE MANUFACTURED ON AFA LINE 9 FROM APRIL 13, 2017 THRU APRIL 15, 2017 AND PACKAGED ON PACKAGING LINE 10 ON APRIL 19, 2017. 7222872- A TOTAL OF 257,210 UNITS WERE MANUFACTURED ON AFA LINE 9 FROM AUG 13, 2017 THRU AUG 18, 2017 AND PACKAGED ON PACKAGING LINE 10 FROM AUG 22, 2017 THROUGH AUG 24, 2017. 7276572- A TOTAL OF 185,610 UNITS WERE MANUFACTURED AFA LINE 9 FROM OCT 11, 2017 THRU OCT 14, 2014 AND PACKAGED ON PACKAGING LINE 10 FROM OCT 15, 2017 THRU OCT 17, 2017. 8058591- A TOTAL OF 396,010 UNITS WERE MANUFACTURED ON AFA LINE 11 FROM APRIL 11, 2018 THRU APRIL 14, 2018. ¿ REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING 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 THESE LOT NUMBERS. RECEIVED A TOTAL OF 55 UNITS AS FOLLOWS: 7165943 ¿ 29 UNITS, 6176525 ¿ 4UNITS, 6342579 ¿ 1 UNITS, 7031846 ¿ 1 UNITS, 7097656 ¿ 3 UNITS, 7222872 ¿ 7 UNITS, 7276572 ¿ 3 UNITS, 8058591 ¿ 7 UNITS, ¿ 7165943: -4 PACKAGES WERE RECEIVED PARTIALLY OPEN AT BOTH ENDS -12 PACKAGES WERE RECEIVED PARTIALLY OPEN AT ONE END -13 PACKAGES RECEIVED WERE NOT OPEN. ¿ 6176525: -2 PACKAGES WERE RECEIVED PARTIALLY OPEN AT BOTH ENDS -2 PACKAGES RECEIVED WERE NOT OPEN. ¿ 6342579: THE PACKAGE RECEIVED WAS PARTIALLY OPEN AT ONE END. ¿ 7031848: THE PACKAGE RECEIVED WAS PARTIALLY OPEN AT ONE END. ¿ 7097656: 3 PACKAGES WERE RECEIVED PARTIALLY OPEN AT BOTH ENDS. ¿ 7222872: -2 PACKAGES WERE RECEIVED PARTIALLY OPEN AT ONE END -1 PACKAGE WAS RECEIVED PARTIALLY OPEN AT BOTH ENDS -4 PACKAGES RECEIVED WERE NOT OPEN. ¿ 7276572: -2 PACKAGES WERE RECEIVED PARTIALLY OPEN AT ONE END -1 PACKAGE RECEIVED WAS NOT OPEN ¿ 8058591: -4 PACKAGES WERE RECEIVED PARTIALLY OPEN AT ONE END -1 PACKAGE WAS RECEIVED PARTIALLY OPEN AT BOTH ENDS -2 PACKAGES RECEIVED WERE NOT OPEN 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. IN ADDITION THE PAPER TOP WEB OF THE RETURNED UNIT WAS ANALYZED UNDER UV LIGHT. THE ADHESIVE USED TO SEAL THE TOP AND BOTTOM WEBS IS UV FLUORESCENT. THE ANALYSIS REVEALED ADEQUATE TOP WEB ADHESIVE. 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. THE DEFECT STATED IN THE DESCRIPTION OF THE COMPLAINT WAS CONFIRMED WITH THE RETURNED UNIT THAT WAS PARTIALLY OPEN AT ONE OR BOTH ENDS. EVEN THOUGH THE PACKAGE WAS RECEIVED PARTIALLY OPENED, ALL THE PROCESS CHARACTERISTICS THAT DIRECTLY INFLUENCE THE SEAL WERE OBSERVED TO BE WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND. 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. EVEN THOUGH SOME OF 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 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. THE PEURA (END USER RISK ANALYSIS): YES REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REV 12 VERSION J WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. CONCLUSION(S): CAPA 48637 WAS INITIATED TO ADDRESS THE ISSUE OF OPEN SEAL COMPLAINTS. TASKS ASSOCIATED WITH THE CAPA PLAN HAVE BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    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: SEX, EVENT ATTRIBUTED TO, DEVICE SINGLE USE?, DEVICE RETURNED TO MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PACKAGING WAS OPEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PACKAGING WAS OPEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7165943; MEDICAL DEVICE EXPIRATION DATE: 2020-05-31; DEVICE MANUFACTURE DATE: 2017-06-14. MEDICAL DEVICE LOT #: 6176525; MEDICAL DEVICE EXPIRATION DATE: 2019-05-31; DEVICE MANUFACTURE DATE: 2016-06-24. MEDICAL DEVICE LOT #: 6342579; MEDICAL DEVICE EXPIRATION DATE: 2019-11-30; DEVICE MANUFACTURE DATE: 2016-12-15. MEDICAL DEVICE LOT #: 7031848; MEDICAL DEVICE EXPIRATION DATE: 2020-01-31; DEVICE MANUFACTURE DATE: 2017-02-01. MEDICAL DEVICE LOT #: 7097656; MEDICAL DEVICE EXPIRATION DATE: 2020-03-31; DEVICE MANUFACTURE DATE: 2017-04-11. MEDICAL DEVICE LOT #: 7222872; MEDICAL DEVICE EXPIRATION DATE: 2020-07-31; DEVICE MANUFACTURE DATE: 2017-08-10. MEDICAL DEVICE LOT #: 7276572; MEDICAL DEVICE EXPIRATION DATE: 2020-09-30; DEVICE MANUFACTURE DATE: 2017-10-03. MEDICAL DEVICE LOT #: 8058591; MEDICAL DEVICE EXPIRATION DATE: 2021-01-31; DEVICE MANUFACTURE DATE: 2018-02-27. 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 THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER PACKAGING WAS OPEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637391 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10. 30382903826446

    Patients

    Seq Age Sex Outcome Treatment
    1 Other