MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

Catalog Number 383021

Device Problem Leak/Splash (1354)

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

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

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 intima-ii¿ closed iv catheter system tubing clamp was defective.The following information was provided by the initial reporter: it was found blood return when clamped the clamp.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system tubing clamp was defective.The following information was provided by the initial reporter: it was found blood return when clamped the clamp.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8107472.Our records show that this is the only instance of this issue occurring in this production batch.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 the pinch clamp of the device submitted was tested by our engineering staff, and found to adhere to the required standards for product conformance.Unfortunately without the ability to replicate the reported failure mode, the root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8668392
• MDR Text Key: 149219069
• Report Number: 3006948883-2019-00427
• Device Sequence Number: 1
• Product Code: NFO
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/12/2021
• Device Catalogue Number: 383021
• Device Lot Number: 8107472
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other