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

Catalog Number 383005

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/05/2019

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 that there was a leak in the bd intima-ii¿ closed iv catheter system packaging before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "there was a leak in the indwelling needle package before puncture, it was replaced immediately.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9169504.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.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.

Event Description

It was reported that there was a leak in the bd intima-ii¿ closed iv catheter system packaging before use.The following information was provided by the initial reporter, translated from chinese to english: "there was a leak in the indwelling needle package before puncture, it was replaced immediately.".

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9553467
• MDR Text Key: 179793253
• Report Number: 3006948883-2019-01172
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/17/2022
• Device Catalogue Number: 383005
• Device Lot Number: 9169504
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other