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

Catalog Number 2C9282

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

This occurred on an unknown date in 2016.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 3-port manifold with check valves cracked.This occurred during infusion of vancomycin.It was stated that the nurse had tried to separate the two and the spike had broken off inside of the manifold.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for sample evaluation.Visual inspection identified that the 3 port manifold was attached to the clearlink system solution set.The parts could not be disconnected and were damaged; part of the luer was broken off inside the manifold port.Attempts to disconnect the parts were unsuccessful.The reported issue of cracked/broken components was verified.The cause of the issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MULTI-PORT MANIFOLD
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; cleveland MS
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5975135
• MDR Text Key: 55563100
• Report Number: 1416980-2016-15570
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C9282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: DUO-VENT CLEARLINK LUER ACTIVATED VALVE; VANCOMYCIN