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

Catalog Number	382554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a bd insyte¿ autoguard¿ bc shielded iv catheter had a broken seal.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Received three iag/bc 16ga units from lot number 6349926.Package was partially opened, but this is the basis of the complaint.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.The defect stated in the description of the complaint was confirmed with two returned packages was partially open at the bottom of the blister pack and one was partially opened at the top of the blister pack.Even though 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.
Event or Problem Description
It was reported that a bd insyte autoguard bc shielded iv catheter had a broken seal.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 7947851
• Report Number: 1710034-2018-00688
• Device Sequence Number: 11326709
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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 Expiration Date: 11/30/2019
• Device Catalogue Number: 382554
• Device Lot Number: 6349926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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