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

Catalog Number 382554

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 sterile breech as "packet adhesive appears degraded, 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 findings: review was previously conducted for this lot (pr 194737-201797 cr) which disclosed the following: lot 6349926: was built on afa line 9 from 20dec2016 through 22dec16 and packaged on packaging line 11 from 27dec2016 through 28dec2016 for the quantity of 109,610ea.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 inspections include but 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.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Observations and testing: received two unused 16ga bd insyte autoguard blood control catheter units within a partially opened package from lot 6349926.All components were present and intact with the blister packs opened at both ends.Visual/microscopic examination: observed that although the unit packages had partially open seal at the top and bottom of the blister pack, the unit packages 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 glue 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 glue.Both of these variables were included in the investigation.Although the packages were partially opened at the top and bottom, the units received and evaluated for this incident were acceptable per the manufacturing specification requirements of the unit packages.There was no physical evidence to confirm or to support manufacturing process related issues for the defect.Capa 48637 was initiated to address the issue of open seal complaints.Tasks associated with the capa plan have been completed.

• 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: 7603010
• MDR Text Key: 111716876
• Report Number: 1710034-2018-00314
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• 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: 11/30/2019
• Device Catalogue Number: 382554
• Device Lot Number: 6349926
• 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