MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8541

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of (b)(6) 2020.(b)(4).Medwatch number: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a cut on the tubing was observed on the two (2) clearlink system continu-flo solution sets.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: two (2) devices were received for evaluation.A visual inspection was done and observed a cut on the tubing and damage to the third y-site.No functional testing was performed for this complaint.The reported condition was verified.The cause of the condition was due to misalignment of the set prior to packaging due to manual handling.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9974474
• MDR Text Key: 188111659
• Report Number: 1416980-2020-02242
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071107
• UDI-Public: (01)00085412071107
• Combination Product (y/n): N
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8541
• Device Lot Number: R19K26036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1