BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC

    MDR report key: 7801630 · Received August 21, 2018

    Report

    Report Number
    1710034-2018-00549
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 19, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826231
    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

    CORRECTION: 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: B.2. EVENT ATTRIBUTED TO: OTHER D.8. DEVICE SINGLE USE?: NO. H.3. DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: SOME RETURNED PACKAGES WERE PARTIALLY OPENED, BUT THIS IS THE BASIS OF THE COMPLAINT. RECEIVED A TOTAL OF 96 UNITS AS FOLLOWS: 6042694 ¿ 13 UNITS, 6146752 ¿ 2 UNITS, 6217513 ¿ 1 UNITS, 6253744 ¿ 3 UNITS, 6348819 ¿ 10 UNITS, 7062502 ¿ 2 UNITS, 7114670 ¿ 2 UNITS, 7157661 ¿ 13 UNITS, 7121766 ¿ 16 UNITS, 7151980 ¿ 2 UNITS, 7250635 ¿ 1 UNITS, 7220671 ¿ 4 UNITS, 7289697 ¿ 2 UNITS, 8009603 ¿ 32 UNITS 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 # 6146752, 6217513 , 7062502, 7114670, 7157661, 7121766, 7151980, 7250635, 7220671, 7289697 AND 8009603 REGARDING ITEM # 383623 COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE WITH LOT # 6042694, 6253744 AND 6348819 REGARDING ITEM # 383623. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. DHR REVIEW: 6042694- A TOTAL OF 284,010 UNITS WERE MANUFACTURED ON AFA LINE 10 18FEB16 THROUGH 23FEB16 AND PACKAGED ON PACKAGING LINE 10 FROM 24FEB16 THRU 26FEB16 6146752- A TOTAL OF 145,210 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 27MAY16 THRU 31MAY16 AND PACKAGED ON PACKAGING LINE 10 FROM 2JUN16 THRU 3JUN16 6217513- A TOTAL OF 186,010 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 8AUG16 THRU 10AUG16 AND PACKAGED ON PACKAGING LINE 10 FROM 10AUG16 THROUGH 11AUG16. TD 2015-79 WAS IN PLACE DURING THE PRODUCTION OF THIS LOT NUMBER. 6253744- A TOTAL OF 110,600 UNITS WERE MANUFACTURED ON AFA LINE 9 FROM 14SEP16 THRU 17SEP16 AND PACKAGED ON PACKAGING LINE 10 FROM 17SEP16 THRU 18SEP16. TD 2015-79 WAS IN PLACE DURING THE PRODUCTION OF THIS LOT NUMBER. 6348819- A TOTAL OF 183,610 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 16DEC16 THRU 19DEC16 AND PACKAGED ON PACKAGING LINE 10 FROM 27DEC16 THRU 29DEC16 7062502- A TOTAL OF 223,010 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 8MAR17 THRU 10MAR17 AND PACKAGED ON PACKAGING LINE 10 FROM 10MAR17THRU 12MAR17 7114670- A TOTAL OF 144,010 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 27APR17 THRU 30APR17 AND PACKAGED ON PACKAGING LINE 10 FROM 30APR17 THRU 1MAY17. QN 200689268 (RUN THROUGH PKG.) WAS INITIATED DURING THE PRODUCTION OF THIS LOT NUMBER. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE PERFORMED AS PER STANDARD OPERATING PROCEDURE. 7157661- A TOTAL OF 180,410 UNITS WERE MANUFACTURED ON AFA LINE 10 ON 18JUN17 THRU 21JUN17 AND PACKAGED ON PKG LINE 10 FROM 20JUN17 THROUGH 22JUN2017. 7121766- A TOTAL OF 147,210 UNITS WERE MANUFACTURED ON AFA LINE FROM 4MAY17 THROUGH 7MAY17 AND PACKAGED ON PACKAGING LINE 10 FROM 10MAY17 THRU 11MAY17. 2 QNS (200691144 AND 200690959) FOR ¿WRINKLE IN SEAL¿ WERE INITIATED DURING THE PRODUCTION OF THE LOT NUMBER. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED AS PER STANDARD OPERATING PROCEDURE. 7151980- A TOTAL OF 184,610 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 1JUN17 THRU 4JUN17 AND PACKAGED ON PACKAGING LINE 10 FROM 3JUN17 THROUGH 5JUN17 7250635- A TOTAL OF 292,610 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 12SEP17 THROUGH 16SEP17 AND PACKAGED ON PACKAGING LINE 10 FROM 13SEP17 THROUGH 17SEP17 7220671- A TOTAL OF 368,010 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 13AUG17 THRU 19AUG17 AND PACKAGED ON PACKAGING LINE 10 FROM 18AUG17 THRU 31AUG17. 7289697- A TOTAL OF 234,410 UNITS WERE MANUFACTURED ON AFA LINE 10 FROM 23OCT17 THROUGH 28OCT17 AND PACKAGED ON PACKAGING LINE 10 FROM 27OCT17 THRU 31OCT17. A NON-RELATED QN (200714654-DAMAGE INSIDE LUER) WAS INITIATED DURING THE PRODUCTION OF THIS LOT. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED PER STANDARD OPERATING PROCEDURE. 8009603- A TOTAL OF 312,210 UNITS WERE MANUFACTURED ON AFA LINE FROM 15JAN18 THRU 19JAN18 AND PACKAGED ON PACKAGING LINE 10 FROM 20JAN18 THRU 23JAN18. A NON-RELATED QN (200729135- RUNNING UNDER MFG. RISK-DOC. NOT RELEASED) AND QN 200729173 (BAD SEAL) WERE INITIATED DURING THE PRODUCTION OF THIS LOT. DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED AS PER. ALL UNITS: 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 SEAL ARE SEAL TRANSFER/WIDTH AND TOP WEB ADHESIVE PRESENCE. BOTH OF THESE VARIABLES WERE INCLUDED IN THE INVESTIGATION. 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. SUPPLIER OLIVER-TOLAS (OT) USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OT. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE OT MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. CAPA 48637 WAS INITIATED TO ADDRESS THE ISSUE OF OPEN SEAL COMPLAINTS. TASKS ASSOCIATED WITH THE CAPA PLAN HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6042694; MEDICAL DEVICE EXPIRATION DATE: 2019-01-31; DEVICE MANUFACTURE DATE: 2016-02-12; MEDICAL DEVICE LOT #: 6146752; MEDICAL DEVICE EXPIRATION DATE: 2019-04-30; DEVICE MANUFACTURE DATE: 2016-05-25; MEDICAL DEVICE LOT #: 6217513 ; MEDICAL DEVICE EXPIRATION DATE: 2019-07-31; DEVICE MANUFACTURE DATE: 2016-08-04; MEDICAL DEVICE LOT #: 6253744 ; MEDICAL DEVICE EXPIRATION DATE: 2019-08-31; DEVICE MANUFACTURE DATE: 2016-09-09; MEDICAL DEVICE LOT #: 6348819; MEDICAL DEVICE EXPIRATION DATE: 2019-11-30; DEVICE MANUFACTURE DATE: 2016-12-22; MEDICAL DEVICE LOT #: 7062502; MEDICAL DEVICE EXPIRATION DATE: 2020-02-29; DEVICE MANUFACTURE DATE: 2017-03-07; MEDICAL DEVICE LOT #: 7114670; MEDICAL DEVICE EXPIRATION DATE: 2020-03-31; DEVICE MANUFACTURE DATE: 2017-04-24; MEDICAL DEVICE LOT #: 7157661; MEDICAL DEVICE EXPIRATION DATE: 2020-05-31; DEVICE MANUFACTURE DATE: 2017-06-06; MEDICAL DEVICE LOT #: 7121766; MEDICAL DEVICE EXPIRATION DATE: 2020-04-30; DEVICE MANUFACTURE DATE: 2017-05-03; MEDICAL DEVICE LOT #: 7151980; MEDICAL DEVICE EXPIRATION DATE: 2020-05-31; DEVICE MANUFACTURE DATE: 2017-05-31; MEDICAL DEVICE LOT #: 7250635; MEDICAL DEVICE EXPIRATION DATE: 2020-08-31; DEVICE MANUFACTURE DATE: 2017-09-07; MEDICAL DEVICE LOT #: 7220671; MEDICAL DEVICE EXPIRATION DATE: 2020-07-31; DEVICE MANUFACTURE DATE: 2017-08-08; MEDICAL DEVICE LOT #: 7289697; MEDICAL DEVICE EXPIRATION DATE: 2020-09-30; DEVICE MANUFACTURE DATE: 2017-10-16; MEDICAL DEVICE LOT #: 8009603; MEDICAL DEVICE EXPIRATION DATE: 2020-12-31; DEVICE MANUFACTURE DATE: 2018-01-09. 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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC, THE PACKAGING WAS SLIGHTLY OPENED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641471 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903826231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other