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

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/11/2019

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 has been reported that one intima-ii y 24gax0. 75in prn/ec slm has been found with loose tubing clamp during use. The following has been provided by the initial reporter: on 9:00 am (b)(6) 2019, when the patient was sealing the tube in the infusion room, the nurse found that the retaining needle infusion clamp could not close tightly, which led to the patient's infusion reflux.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9192696
• MDR Text Key: 179488378
• Report Number: 3006948883-2019-00865
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/20/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8141415
• 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: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/15/2019 Patient Sequence Number: 1