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

Catalog Number 3C0162

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a clearlink continu-flo solution set would not connect to an unspecified intravenous set.The reporter stated that the set would not tighten.This occurred during set-up after priming the set.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information/correction: upon follow-up, the reporter stated that the set had not been unable to connect.The device was not received for evaluation; therefore, a device analysis could not be 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4965439
• MDR Text Key: 6324189
• Report Number: 1416980-2015-31347
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2018
• Device Catalogue Number: 3C0162
• Device Lot Number: GR311431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• 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
• Patient Sequence Number: 1