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

Catalog Number	382554
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the packaging of the bd insyte¿ autoguard¿ bc shielded iv catheter appeared to be degraded.The adhesive seal is opening spontaneously.Therefore, the product is no longer sterile.Found before use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
H.6.Investigation summary: device/bath history review findings: as this complaint was an mdr, dhr review was performed on the lot number 5219921.The product was manufactured on afa line 9 from august 13, 2015 thru august 14, 2015 and packaged on packaging line 11 from august 21, 2015 thru august 21, 2015.Review of the dhr¿s revealed all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact the quality of the product.Set-up and in-process inspections (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test.These were performed on various stages throughout the process and all the inspections passed per specifications.Visual analysis: observations and testing: received 15 unused iag/bc 16ga units in partially opened package from the lot number 5219921.Visual/microscopic examination: two of the packages were partially opened at both ends of the blister pack.Two of the packages were partially opened at the top of the blister pack.Two of the packages were partially opened at the bottom of the blister pack.The seals of the remaining nine packages were not compromised.The analysis of top web adhesive: 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.The analysis revealed an adequate of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were looked at during the investigation.Investigation conclusion: relationship of device to the reported incident: indeterminate.Comment: although the packages were observed to be partially opened, there was no physical evidence to confirm or to support manufacturing process related issues for the defect.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7601863
• Report Number: 1710034-2018-00317
• Device Sequence Number: 1555273
• Product Code: FOZ
• UDI-Device Identifier: 00382903825547
• UDI-Public: 00382903825547
• 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,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 07/31/2018
• Device Catalogue Number: 382554
• Device Lot Number: 5219921
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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