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

Catalog Number 381844

Device Problems Unsealed Device Packaging (1444); 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, a supplemental report will be filed.

Event Description

It was reported that the seal on the bd insyte autoguard shielded iv catheter was open prior to use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation results: one sample unit was received for evaluation by our quality engineer team.Upon examination, the unit was observed to be partially open at both ends of the blister packaging.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.Proper personnel have been notified of this issue for further review.Lot analysis: device/batch history record review: yes: reason: dhr¿s are available for reviews as needed and are required for quality issues relating to product traceability or if the reported incident is a medical device reportable (mdr).This investigation is mdr.Findings: a total of (b)(4) units were manufactured on afa line 8 from 8 feb 2015 through 13 feb 2015 and packaged on packaging line 11 from 11 feb 2015 through 14 feb 2015.In process inspections (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.Qn / sap database review: yes.Reason: dhr was reviewed findings: see findings on dhr review.The peura (end user risk analysis): yes, review of the peura is required for all mdr reportable investigations.Findings: (b)(4) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.Visual analysis observations and testing: received one unused 18ga insyte autoguard unit from lot number 5037912.Visual/microscopic examination: the unit received was partially open at both ends.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.Was the device used for treatment or diagnosis? treatment.Conclusions: the defect stated in the event description was confirmed with the returned unit.Even though the reported defect was confirmed, all the processes characteristics that directly influence the seal strength were observed to be within specification.No anomalies were found.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 units.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.Other actions taken (if applicable): product quality is evaluated during the manufacturing and packaging process with prescribed attributes inspections.These inspections are performed by operators to ensure any gross process changes are identified.If defects are observed, disposition of the product, root cause and corrective action(s) are applied according to the quality control plan.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7147980
• MDR Text Key: 95952006
• Report Number: 1710034-2017-00525
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818440
• UDI-Public: 00382903818440
• 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: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 381844
• Device Lot Number: 5037912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Date Manufacturer Received: 11/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other