MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2020

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. Fda device problem code: 1354, fda patient problem code: 2645.

Event Description

It was reported that intima-ii y 24gax0. 75in prn/ec slm tubing clamp was defective. The following information was provided by the initial reporter: on (b)(6) 2020, when preparing to use a closed venous indwelling needle for puncture infusion for the parturients, the open inspection found that the indwelling needle sealing tube clamp could not be clamped and could not be used, that is, that is, replaced the intravenous indwelling needle for reuse.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11029053
• MDR Text Key: 222697466
• Report Number: 3006948883-2020-00997
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383033
• Device Lot Number: 0202466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial