MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND ACCESS; STOPCOCK, I.V. SET

Catalog Number 2C5601

Device Problem Failure to Disconnect (2541)

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

Event Date 10/17/2013

Event Type  malfunction  

Event Description

It was reported that nurse was unable to disconnect unknown iv set tubing from stopcock of a 4-way stopcock with rotating male luer lock.Customer also stated that the plastic between the two stopcocks broke when nurse was trying to disconnect the tubing.There is no report of patient/user injury or medical intervention was needed in association with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A batch review will be performed.A request for the return of the device has been made.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Upon receipt of the sample, it was determined that this was not a product manufactured by baxter.The unknown device was returned to the customer and no evaluation was performed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north po box 1; cleveland MS 38732
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3689172
• MDR Text Key: 4289545
• Report Number: 1416980-2014-09158
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C5601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN IV SET