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

Catalog Number 3C0162

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Therapy dates - the exact occurrence date is unknown; however, the event was reported to have occurred in the six months prior to the report.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the male luer adapter of a clearlink continu-flo solution set did not connect properly to a non-baxter catheter, leading to a leak at the connection.This occurred during gravity infusion of normal saline.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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: 5010465
• MDR Text Key: 23260364
• Report Number: 1416980-2015-32755
• 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: company representative,other
• Reporter Occupation: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3C0162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE