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

Catalog Number 382544

Device Problems Degraded (1153); Device Disinfection Or Sterilization Issue (2909)

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 the packaging of a bd insyte autoguard bc shielded iv catheter was found degraded and opening spontaneously breaching sterility.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: device/batch history record review findings: the review was conducted on lot 5355581.It was built on afa line 9 from 29dec2015 through 04jan2016 and packaged on packaging line 11 from 06jan2016 through 07jan2016 for the quantity of 115,610ea.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 two non-related qns and no related 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.Sap (qn) database review findings: subject code was an s1 severity ranking.Review was conducted for this mdr-level a investigation which disclosed the following: there were two non-related qns and no related reject activity findings relevant to the defect stated in the pir associated with the lot number provided for this incident.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 one unused 18ga bd insyte autoguard blood control catheter unit within a partially opened package from lot 5355581.All components were present and intact with the blister pack was partially opened at both ends.Visual/microscopic examination: observed that although the unit package had a partially opened seal at the top and bottom of the blister pack and the sterility barrier was compromised at the bottom end.The unit package (blister pack) demonstrated to have had an adequate seal with no anomalies at time of manufacturing.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.Conclusions: confirmation of the defect of package seal integrity poor / questionable, stated in the complaint description, was conclusive with the unit provided for this incident as the unit was received with partially opened packaging (blister pack).Although the package was received partially opened at the top and bottom, all the process characteristics that directly influence the seal strength were observed to be within specification.No anomalies were found.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: 7606884
• MDR Text Key: 111719134
• Report Number: 1710034-2018-00308
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825449
• UDI-Public: 30382903825449
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 382544
• Device Lot Number: 5355581
• 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: 06/15/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other