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

Catalog Number 382534

Device Problems Device Operates Differently Than Expected (2913); Packaging Problem (3007)

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

Event Date 02/05/2018

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 before use of the bd insyte¿ autoguard¿ bc shielded iv catheter ¿it was noticed in recovery and the icu the edge of the packaging was not sticking properly and is opening without force.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: lot analysis: per review of the dhr¿s 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.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.Visual analysis: observations and testing: received two unused iag 20ga unit in partially opened packages from the lot number; 7131877.Visual/microscopic examination: one package was opened at the bottom of the blister pack.One package was opened at the top of the blister pack.The analysis of top web adhesive: 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 an adequate of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both variables were looked at during the investigation.Investigation conclusion: the defect package seal integrity poor/questionable, as stated as the reported coded was confirmed with the returned unit.Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found.

• 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: 7334976
• MDR Text Key: 102342033
• Report Number: 1710034-2018-00117
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825340
• UDI-Public: 30382903825340
• 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: 06/01/2018

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: 04/30/2020
• Device Catalogue Number: 382534
• Device Lot Number: 7131877
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other