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

Catalog Number 2C8931

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Event Description

It was reported that a clearlink continu-flo 3 port manifold came ¿apart in the lower portion¿.The components involved in the separation/disconnection were not specified.Patient involvement and the step of setup or therapy during which this occurred are unknown, though the reporter stated that the patient would lose blood if this was not caught right away.During follow up with the reporter, they stated that the separation was due to the operator not tightening the in-line connections per the labeling instructions.There was no report of patient injury or medical intervention associated with this event.Additional information was requested and is not available.This is report 1 of 3.

Manufacturer Narrative

(b)(4).Event date and concomitant (therapy dates) - the event occurred sometime between (b)(6) 2014.Should additional relevant information become available, a follow up report will be submitted.

• Brand Name: ACCESS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL; parque industrial itabo, zona; haina ; DR
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4207676
• MDR Text Key: 19802337
• Report Number: 1416980-2014-37775
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8931
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2014
• 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