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

Catalog Number 382533

Device Problems Backflow (1064); Fluid/Blood Leak (1250); Defective Device (2588)

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

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8304898.Medical device expiration date: 2021-10-31.Device manufacture date: 2018-11-12.Medical device lot #: 8310640.Medical device expiration date: 2021-10-31.Device manufacture date: 2018-11-06.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.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 4 bd insyte¿ autoguard¿ bc shielded iv catheters from lot # 8304898, and 1 catheter from lot # 8310640 had defective valve port plugs that would not engage when pressed, causing blood to back up and leak out during use.The following information was provided by the initial reporter: "health professional called to report that on 5 catheters the valve port plug is not engaging when pressed so blood is backing up and leaking out.".

Event Description

It was reported that 4 bd insyte¿ autoguard¿ bc shielded iv catheters from lot # 8304898, and 1 catheter from lot # 8310640 had defective valve port plugs that would not engage when pressed, causing blood to back up and leak out during use.The following information was provided by the initial reporter: "health professional called to report that on 5 catheters the valve port plug is not engaging when pressed so blood is backing up and leaking out.".

Manufacturer Narrative

H.6.Investigation summary: dhr: lot number was built and packaged on afa 11 from 06nov2018 through 11nov2018 for the quantity of 448.810 ea.All required challenge samples, set-up and testing was conducted per specifications and in accordance with the in-process sampling plans.There were no indications of reject activity throughout the build of this lot that would impact the outcome of the quality of the product relevant to the reported defect stated in the pir.Observations and/or testing; was not conducted because units were not provided for this incident for the alleged defect of blood leaks out of control plug.Conclusion(s): relationship of device to the reported incident: indeterminate no units (samples) or photos were provided for observation or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.

• 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: 8565482
• MDR Text Key: 145113993
• Report Number: 1710034-2019-00470
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 382533
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other