MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD; STOPCOCK, I.V. SET

Catalog Number 2C8931

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a leak from a clearlink continu-flo multi-port manifold, leading to blood loss.The reporter stated that an extra manifold and stopcock had been attached to the set, but the connections had not been fully tightened.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).Additional information: the device was not returned, however a photograph was received for evaluation.A visual inspection of the photograph showed a section of a leaking set.The reported condition was verified.It was confirmed that the clinician involved attached an extra manifold and stopcock to the set and did not tighten the connections.Therefore, the cause of the condition was determined to be a use error.Label instructions state, "ensure all in-line luer connections are secure prior to use." should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO MULTI-PORT MANIFOLD
• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5638590
• MDR Text Key: 44668833
• Report Number: 1416980-2016-08612
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

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: No Information
• Device Catalogue Number: 2C8931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: No
• 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