MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER INTRAVASCULAR CATHETER

Catalog Number 386807

Device Problems Fluid Leak (1250); Defective Component (2292)

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

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6). 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 bd cathena¿ safety iv catheter the anti reflex valve does not function after insertion or connection/disconnection and there was blood leaking past the valve and out of the hub. Insertion was observed on live patient, steps for insertion were performed correctly, and as soon as the needle was pulled out of the hub, the blood would leak up by following the spring inside the catheter hub. Connection with a saline flush was performed, after disconnection, catheter leaked
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valve not functioning either. Repeated this twice, with the same result.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8395584
• MDR Text Key: 138238126
• Report Number: 8041187-2019-00205
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 386807
• Device Lot Number: 8208411
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2018
• 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: 03/06/2019 Patient Sequence Number: 1