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

Catalog Number 381844

Device Problems Material Rupture (1546); Problem with Sterilization (1596)

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

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter had a rupture in the packaging that broke the sterile barrier.No serious injury or medical intervention was reported.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheter had a rupture in the packaging that broke the sterile barrier.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: received three iag 18ga unit from lot number 7310924.Package was partially opened, but this is the basis of the complaint.Dhr review was performed on the lot number 7310924.The lot number was built on afa line 8 from 12nov2017 thru 18nov2017.Packaged on packaging line 8 from 12nov2017 thru 18nov2017.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.Investigation conclusion: 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 of these 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 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.Root cause description: 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.Rationale: capa 48637 was opened to investigate the package seal integrity complaints and implement corrective actions.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that due to low occurrence, current risk is acceptable.

• 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: 8034508
• MDR Text Key: 126410929
• Report Number: 1710034-2018-00801
• 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: 01/02/2019

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: 10/31/2020
• Device Catalogue Number: 381844
• Device Lot Number: 7310924
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other