MAUDE Adverse Event Report: CLEARLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H8486

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system non-dehp solution set filled with air.It was stated that the set was primed for use with enteral nutrition.When the nurse inverted the filter to attach the line to the patient's central line, the line began to fill with air from the male luer adapter back toward the filter.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12461480
• MDR Text Key: 271080575
• Report Number: 1416980-2021-05623
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412074764
• UDI-Public: (01)00085412074764
• Combination Product (y/n): Y
• PMA/PMN Number: K952074
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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: Health Professional
• Device Catalogue Number: 2H8486
• Device Lot Number: R20J17034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/13/2021
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENTERAL NUTRITION.; ENTERAL NUTRITION