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

Catalog Number 382534

Device Problems Degraded (1153); Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use a bd insyte¿ autoguard¿ bc shielded iv catheter was found with breach integrity as "packet adhesive appears degrades, packets opening spontaneously therefore no longer sterile." there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

H.6.Investigation summary: lot analysis lot 6237836 was built and packaged on afa line 11 from 31aug2016 through 03sept2016for the quantity of 264,010ea.It was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.It was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Set-up and in-process inspections included but were not limited to blister thickness, bad seal/cut/holes, seal transfer width and package leak test.These were performed on various stages throughout the process, all the inspections passed per specifications.Visual analysis observations and testing: received two unused 22ga bd insyte autoguard blood control catheter units within sealed packages from lot 6237836.All components were present and intact with the blister pack was properly sealed at both ends.Visual/microscopic examination: observed that the unit packages demonstrated to have had an adequate seal with no anomalies at time of manufacturing.Note: the product characteristics require a minimum of 1/8¿ seal transfer.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 seal strength are: seal transfer/width and top web adhesive presence.Both of these variables were included in the investigation.Investigation samples(s) meet manufacturing specifications: yes: the packages were not opened at either the top or bottom.The units (blister packs) returned for this incident were acceptable per the manufacturing specification requirements of the unit package.Investigation conclusion: confirmation of the defect of package seal integrity poor / questionable, stated in the description of the complaint, was inconclusive with the units provided for this incident as the units were received with uncompromised unit packaging (blister packs).Confirmed the process characteristics that directly influence the seal were observed to be within specification.Root cause: relationship of device to the reported incident: indeterminate - the packages were received sealed; there was no physical evidence to confirm or to support manufacturing process related issues for the alleged defect.Although the defect experienced by the customer was not confirmed with this particular incident, the failure is a known issue and was investigated under capa 48637.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7603051
• MDR Text Key: 111708845
• Report Number: 1710034-2018-00313
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: 30382903825340
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 382534
• Device Lot Number: 6237836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other