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

Catalog Number 382533

Device Problem Material Fragmentation (1261)

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

Event Date 06/12/2018

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 that a bd insyte¿ autoguard¿ bc shielded iv catheter contained foreign matter covered with small shredded pieces of plastic on the catheter. Found before use. No report of serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: the device history report for lot number 8061541 was reviewed, no related abnormalities were found. Material number 382533 for lot8 061541 was manufactured on 12/08/2017 - 12/11/2017. This is the first instance of this failure mode with this lot number. According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections. Additionally a sample was submitted for the purpose of aiding our quality engineer in their investigation. Visual observation of the device determined that the catheter tubing had clear plastic fibers on the exterior of the device. Investigators determined that the failure mode was caused by the manufacturing process. Investigation conclusion: foreign matter can be loosely attached to the catheter tubing due to the silicone lube during the manufacturing process.

Event Description

It was reported that a bd insyte¿ autoguard¿ bc shielded iv catheter contained foreign matter covered with small shredded pieces of plastic on the catheter. Found before use. No report of serious 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: 7653052
• MDR Text Key: 113004313
• Report Number: 1710034-2018-00373
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 382533
• Device Lot Number: 8061541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/29/2018 Patient Sequence Number: 1