MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 2C6218

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Skin Tears (2516)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: staff spec.Center for quality/safety.Medwatch uf/importer report # (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the three gang large bore stopcock manifold is rigid and is ¿getting behind patients and causing skin breakdown¿; further described as pressure indents to the patients¿ backs (no further detail was provided).No further information was provided regarding the number of patients.It was not reported if the patients required medical intervention.Patient outcomes were not reported.No additional information is available.

Manufacturer Narrative

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: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6297910
• MDR Text Key: 66428265
• Report Number: 1416980-2017-00848
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Catalogue Number: 2C6218
• Device Lot Number: DR15L14042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other