MAUDE Adverse Event Report: BD (SUZHOU) BD INSIGHT-A ¿ CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382803

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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 insight-a ¿ catheter there was an issue with catheter adopter bent.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8137337.Our records show the reported lot was manufactured in june of 2018 , and determined that this is the only instance of this issue occurring in this batch of insyte-a.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, in response to the damage observed in the sample provided our engineering team launched a review of the manufacturing, inspection, and packaging processes.During their review they were unable to identify any potential abnormalities that could have led to the reported event.Based on these findings, our engineers speculate that the most probable root cause for this occurrence is the application of force to the device during shipment or storage, however this cannot be confirmed to at this time.

Event Description

It was reported with the use of the bd insight-a ¿ catheter there was an issue with catheter adopter bent.

• Brand Name: BD INSIGHT-A ¿ CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8199714
• MDR Text Key: 131708354
• Report Number: 3006948883-2018-00315
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 382803
• Device Lot Number: 8137337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other