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

Catalog Number 382512

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

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 the adhesive on the packaging seal of the bd insyte¿ autoguard¿ bc shielded iv catheter appears degraded.Therefore, the product is no longer sterile.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

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 Description

It was reported that the adhesive on the packaging seal of the bd insyte autoguard bc shielded iv catheter appears degraded.Therefore, the product is no longer sterile.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: device/batch history record review: lot 5191735 was built on afa line 10 from 12jul2015 through 17jul2015 and packaged on packaging line 9 from 20jul2015 through 22jul2015 for the quantity of (b)(4).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.Analysis of peura and/or fmea conducted by qe: rm5835 rev 12 version j was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Visual analysis observations and testing: received two unused 24ga bd insyte autoguard blood control catheter unit within a partially opened packages from lot 5191735.All components were present and intact with the blister packs partially opened at the top and bottom ends.Visual/microscopic examination: observed that although the returned units had the partially opened seal at the top of the blister packs and the sterility barrier was compromised, the unit packages (blister pack) demonstrated to have had an adequate seal with no anomalies related to the manufacturing specifications.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 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.

Event Description

It was reported that the adhesive on the packaging seal of the bd insyte¿ autoguard¿ bc shielded iv catheter appears degraded.Therefore, the product is no longer sterile.Found before use.No reports of serious injury or medical intervention noted.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7601917
• MDR Text Key: 111701231
• Report Number: 1710034-2018-00298
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: 00382903825127
• 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,Followup
• Report Date: 09/04/2018

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: 06/30/2018
• Device Catalogue Number: 382512
• Device Lot Number: 5191735
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other