MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTERVASCULAR CATHETER

Catalog Number	381467
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5232532, medical device expiration date: 2018-07-31, device manufacture date: 2015-08-20.Medical device lot #: 6215627, medical device expiration date: 2019-07-31, device manufacture date: 2016-08-03.Medical device lot #: 6308948, medical device expiration date: 2019-10-31, device manufacture date: 2016-11-08.Medical device lot #: 6042643, medical device expiration date: 2019-01-31, device manufacture date: 2016-02-12.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ shielded iv catheter had sterile breach.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the returned unit and photograph provided by your facility.Bd received four insyte autoguard 14ga packages from lot number: 5232532.A device history record review showed no non-conformances associated with this issue during the production of this batch.The set-up and in process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak tests were performed on various stages throughout the manufacturing packaging process, all the inspections passed per specifications.The analysis of the top web adhesive where the product characteristics require a specific seal transfer was met per specifications.In addition, the paper top web of the returned units were analyzed under a uv light.The glue used to seal the top and bottom webs is uv fluorescent.This analysis revealed an adequate amount of top web adhesive.The key variables that affect seal strength are seal transfer/width and top web glue.Both variables were looked at during the investigation.The returned units provided for evaluation for this incident met the manufacturing specification requirements.In conclusion, where the packages were found partially opened, the process characteristics that directly influence the seal strength (seal transfer and top web glue), measured within specification.Investigation conclusion: the defect stated in the description of the complaint was confirmed with the returned unit.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.Unable to determine a root cause.Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ shielded iv catheter had sterile breach.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7709462
• Report Number: 1710034-2018-00430
• Device Sequence Number: 11095052
• Product Code: FOZ
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 381467
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/22/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other