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

Catalog Number 382544

Device Problem Degraded (1153)

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Initial reporter fax#: (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 seal on a bd insyte¿ autoguard¿ shielded iv catheter appears degraded, packets opening spontaneously therefore no longer sterile.No injury or medical intervention.

Manufacturer Narrative

Investigation summary: lot analysis lot 6119804 was built on afa line 9 on 06may2016 thru 10may2016 and packaged on packaging line 11 for the quantity of 428,210ea.Review of dhr revealed all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the event description.Visual analysis observations and testing: received 2 insyte autoguard bc 18ga units from lot number 6119804 exp.2019-04-30.Visual/microscopic examination: both of the packages received were partially open at both ends.The product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.This characteristic was met.In addition the paper top web of the returned units 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 samples(s) meet manufacturing specifications: yes; although the defect was confirmed, the unit evaluated for this incident was acceptable per the manufacturing specification requirements of the package.Investigation conclusion: the defect stated in the description of the complaint was confirmed with the returned unit.Even though the package was received partially opened, all the process characteristics that directly influence the seal were observed to be within specification.No anomalies were found.Root cause: relationship of device to the reported incident: indeterminate 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.Capa 48637 was initiated to address the issue of open seal complaints.

• 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: 7613495
• MDR Text Key: 111903895
• Report Number: 1710034-2018-00300
• 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,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: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 382544
• Device Lot Number: 6119804
• 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