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

Catalog Number 382554

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd insyte¿ autoguard¿ bc shielded iv catheter ¿packaging is not sticking properly and is opening without any force required.¿ found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

H.6.Investigation summary: bd received one unsued sample from the customer in support of this complaint.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.The samples were visually and microscopically evaluated and the customer's indicated failure mode for poor package seal integrity with the incident lot was not observed.Lot analysis device/batch history record review: yes findings: as this complaint was a mdr; -dhr review was performed on the lot number 6349926 the lot number was packaged on packaging line 11 from december 27, 2016 thru december 28, 2016.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.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product 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.Qn / sap database review: no.Reason: a review of the qn/sap database is not required for a s2 ¿ o1 level a investigation per cpr ¿ 071 visual analysis observations and testing: received one unused iag/bc 16ga unit in partially opened package from the lot number; 6349926.Visual/microscopic examination: the 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 samples(s) meet manufacturing specifications: yes; the returned unit provided for evaluation for this incident met the manufacturing specification requirements in regard to package seal integrity poor/questionable.Conclusions: the defect package seal integrity poor/questionable, as stated as the reported coded was confirmed with the returned unit.Even though the package 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.Investigation conclusion: root cause relationship of device to the reported incident: indeterminate comment: package seal integrity: 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.

• 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: 7314740
• MDR Text Key: 101709538
• Report Number: 1710034-2018-00076
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825547
• UDI-Public: 00382903825547
• 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: 03/14/2018

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 Catalogue Number: 382554
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other