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

Catalog Number 382554

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 10/12/2018

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 with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with sterile breach.There was no report of injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: dhr- the product was manufactured on afa line 9 from march 24, 2017 thru march 25, 2017 packaged on packaging line 11 from april 5, 2017 thru april 6, 2017.All challenge samples, set-up and in process testing were performed and all passed per specifications.No quality notifications were initiated during production.Received one iag unit from lot number 7076873, all components within were present and intact.The unit received was partially open at one end.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.Conclusion(s): supplier ¿ defective material 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.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter there was an issue with sterile breach.There was no report of injury or medical intervention.

• 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: 8052547
• MDR Text Key: 126922484
• Report Number: 1710034-2018-00809
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825548
• UDI-Public: 30382903825548
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 382554
• Device Lot Number: 7076873
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other