MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number 2C6254

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a follow-up will be submitted.

Event Description

A one-link intravenous (iv) extension set disconnected while in use on a patient and causing blood loss.It was reported the patient was being brought up from the operating room and the iv tubing disconnected from the ¿purple luer lock¿ causing a loss of the iv access and blood loss.The issue was further described as ¿the end cap came off of the extension tubing¿ (not further specified).The amount of blood loss was not reported, however, was further described as ¿a severe occurrence¿.It was reported that once they got the patient back to bed, it was noted that there was an additional loose connection in the tubing in addition to the portion that became disconnected (no further detail was provided).No further information was provided regarding medical intervention or regarding the patient¿s outcome from the event.No additional information is available.

Manufacturer Narrative

Upon follow up with the customer, clarification was received that only one disconnection had occurred during the event (¿the end cap came off of the extension tubing¿).The set in use at the time was clarified to be a clearlink continu-flo solution set 4-way stopcock extension set.The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed that the female luer had disconnected from the stopcock.The reported condition was verified.The cause of the condition could not be determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• 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 00705 ; DR 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6332428
• MDR Text Key: 67485865
• Report Number: 1416980-2017-01299
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening