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

Catalog Number	2C6700
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 1 malfunction events.It was reported that the spike of an interlink straight type blood set broke off in the blood transfusion bag, leading to a leak.This occurred when the nurse spiked the bag during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
One single-use sample was received for evaluation.The returned unit was contaminated with blood when received.A visual inspection was performed through the bag and no issues were noted.The reported condition could not be verified during visual inspection.Further evaluation was not performed due to the condition of the sample.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: INTERLINK BLOOD RECIPIENT SET
• Common Device Name: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8541743
• Report Number: 1416980-2019-02200
• Device Sequence Number: 13543340
• Product Code: BRZ
• UDI-Device Identifier: 00085412068152
• UDI-Public: (01)00085412068152
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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: 2C6700
• Device Lot Number: R18F15021
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1