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

Catalog Number 381823

Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)

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

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that ¿the package was turned over¿.After bd received the customer sample of the bd insyte¿ autoguard¿ shielded iv catheter, it was determined that the package was open, thus a sterile breach.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: one sample unit was received for evaluation by our quality engineer team.Upon examination, the package was observed to be open at both ends of the blister pack.The packages were analyzed under uv light as the adhesive used is uv fluorescent.The analysis revealed an adequate amount of top web adhesive.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.Lot analysis device/batch history record review: yes findings: as this complaint was a mdr; -dhr review was performed on the lot number 5219908 the lot number was packaged on packaging line 8 from august 9, 2015 thru august 14, 2015.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 one unused iag 22ga unit in partially opened package from the lot number; 5219908.Visual/microscopic examination: the package was opened at the both ends 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 of these variables were looked at during the investigation.Investigation samples(s) meet manufacturing specifications: yes; the returned unit provided for evaluation for this incident met the manufacturing specification requirements in regards to package seal integrity poor/questionable.Investigation conclusion: the defect package seal integrity poor/questionable as stated in the description of the complaint was confirmed with the returned unit.No anomalies were found and all the process characteristics that directly influence the seal strength were observed to be within specification.The units were acceptable per specification requirements.Did the evaluation confirm the customer's experience with the bd product? yes; the customer experience was confirmed based on the evaluation that was performed on the returned unit.Were we able to reproduce the customer's experience with the bd product? no; it was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed.Relationship of device to the reported incident: indeterminate comment: 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 (b)(4) has been opened to investigate the package open seal defects and implement corrective actions.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 7183970
• MDR Text Key: 97482909
• Report Number: 1710034-2017-00532
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• 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: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 381823
• Device Lot Number: 5219908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Date Manufacturer Received: 12/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other