MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N8378

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that clearlink system non-dehp catheter extension set was defective which resulted in a blood leak.The defect was described as a slice.The defect was also described as a distorted lumen that was "much more flat/narrow than a typical extension set should be".It was further reported that the tubing appeared to be narrow at 2 cm around the defect.The leak was observed while the patient was connected for therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received contaminated with blood.Visual inspection was performed which observed a hole on the tubing.The reported condition was verified.The cause of the condition was not determined; however, the potential cause could be related to the packaging machine.Due to the nature of the returned sample, no functional testing could be performed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10067101
• MDR Text Key: 191310217
• Report Number: 1416980-2020-02774
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048918
• UDI-Public: (01)00085412048918
• Combination Product (y/n): N
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N8378
• Device Lot Number: UR19K26010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1