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

Catalog Number 381812

Device Problem Problem with Sterilization (1596)

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

Event Date 12/03/2018

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 that bd¿ insyte autoguard shielded iv catheter had sterility breach.

Event Description

It was reported that bd¿ insyte autoguard shielded iv catheter had sterility breach.This malfunction affected 5 devices.

Manufacturer Narrative

Correction: describe event or problem: it was reported that bd¿ insyte autoguard shielded iv catheter had sterility breach.This malfunction affected 5 devices.Investigation summary: dhr review was performed on lot number 6130990; the lot number was manufacture on afa line 4 from (b)(6) 2016.Packaging line 9 from (b)(6) 2016.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality 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 pir.No quality notification were initiated during the build of this lot number.Received five iag 24ga units from lot number 6130990.Package was partially opened, but this is the basis of the complaint.Visual/microscopic evaluation: 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.The key variables that affect the packaging seal are seal transfer/width and top web adhesive presence.Both variables were included in the investigation.The defect stated in the description of the complaint was confirmed with the returned units that was partially open at the top and bottom of the blister pack.Even though the packages were received partially opened, all the process characteristics that directly influence the seal were observed to be within specification.No anomalies were found.Bd supplier oliver-tolas (ot) 29lp uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to oliver-tolas.There is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.Due to continuous issues with ot, bd is moving to an alternate supplier for the top web material.Capa 48637 was opened to investigate the package seal integrity complaints and implement corrective actions.

• Brand Name: BD¿ INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: PERIPHERAL VASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8190204
• MDR Text Key: 131194347
• Report Number: 1710034-2018-00919
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818129
• UDI-Public: 00382903818129
• 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: 01/17/2019

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: 04/30/2019
• Device Catalogue Number: 381812
• Device Lot Number: 6130990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other