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

Catalog Number	2H8631
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of clearlink system non-dehp extension set separated from the y connector closest to the patient.This was identified when it was removed from the packaging.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection was performed, and it was noted that the tubing was separated from the second y -site clearlink in the upstream part.It was also observed that there was a lack of solvent (the solvent was not applied uniform around the circumference of the tube) during examination of the tubing.Dimensional testing was performed, and the tubing and clearlink y-site housing were according to specification.Insertion of the tubing and second y-site clearlink was also according to specification.The reported condition was verified.The cause of the reported condition was due to inadequate application of the solvent quantities on tubing and y-site joint during the manufacturing process.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10240927
• Report Number: 1416980-2020-03819
• Device Sequence Number: 2433219
• Product Code: FPA
• UDI-Device Identifier: 00085412080949
• UDI-Public: (01)00085412080949
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2020

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
• Operator of Device: Other
• Device Catalogue Number: 2H8631
• Device Lot Number: R19J09042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1