MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

Catalog Number	2C8720
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Two single use devices have been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 2 malfunction events.It was reported that two clearlink y-type blood/solution sets leaked from an unspecified location.This occurred before patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: two single-use devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were found to be correctly placed and per specifications, and no separations between the components was observed.Pressure testing and clear passage testing under water were performed for both devices with no issues noted.The reported condition was not verified or the returned devices.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 BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8015327
• Report Number: 1416980-2018-06896
• Device Sequence Number: 1368620
• Product Code: BRZ
• UDI-Device Identifier: 00085412049083
• UDI-Public: (01)00085412049083
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 2C8720
• Device Lot Number: R18F08075
• Initial Date Received by Manufacturer: 09/30/2018
• Supplement Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/30/2019
• Patient Sequence Number: 1