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	08/24/2018
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 sterile breach due to packaging adhesive failure.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter had sterile breach due to packaging adhesive failure.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: dhr review was performed on the lot number 6042686: the lot number was manufactured on afa line 9 from february 16, 2016 thru february 18, 2016 packaged on packaging line 11 from february 19, 2016 thru march 12, 2016 review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed two non-related qn¿s were initiated during the build of this lot that would not impact the outcome of the quality of the product relevant to the reported defect.Received one iag bc 16ga unit from lot number 6042696.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 the returned unit that was partially open at one end.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.Conclusion(s): bd supplier (b)(4) 29lp uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to (b)(4) there is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.Due to continuous issues with (b)(4), bd is moving to an alternate supplier for the top web material.Capa (b)(4) was opened to investigate the package seal integrity complaints and implement corrective actions.

• 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: 7878166
• Report Number: 1710034-2018-00635
• Device Sequence Number: 2725785
• 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): 11/19/2018

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: 02/28/2019
• Device Catalogue Number: 382554
• Device Lot Number: 6042686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/20/2018
• 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