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

Catalog Number 382512

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(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 before use a bd insyte¿ autoguard¿ bc shielded iv catheter was found with package seal 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

Investigation summary: device/batch history record review: lot 6113640; was built on afa line 10 from 27apr2016 through 29apr2016 and packaged on packaging line 9 from 29apr2016 through 30aprc2016 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.All set-up and in-process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test 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 one unused 24ga bd insyte autoguard blood control catheter unit within a partially opened package from lot 6113640.All components were present and intact with the blister pack partially opened at the top end.Visual/microscopic examination: observed that although the returned unit had the partially opened seal at the top of the blister pack and the sterility barrier was compromised, the unit package (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 package was 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 before use a bd insyte¿ autoguard¿ bc shielded iv catheter was found with package seal integrity as "packet adhesive appears degrades, packets opening spontaneously therefore no longer sterile."there was no report of exposure, injury or medical intervention needed.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7579451
• MDR Text Key: 110714681
• Report Number: 1710034-2018-00302
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825128
• UDI-Public: 30382903825128
• 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: 07/26/2018

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
• Device Operator: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 382512
• Device Lot Number: 6113640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other