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

Catalog Number 2C6750H

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Lot #: the reported lot # was dr19814029 ; however, this lot number was not recognized by baxter.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Hold for erika 12.05 it was reported that platelets were leaking coming from a hole in the tubing of interlink system y-type blood/solution set.This was identified during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

D4 lot #: the correct lot # is dr19h14029 , previously submitted dr19814029 (not recognized by baxter) d4: expiration date: 08/19/2024, previously submitted as ni.D4: unique identifier (udi) #: (b)(4).H10: the actual sample was received for evaluation.Visual inspection was performed and a cut in the tubing was identified.The reported problem was verified during initial inspection.A functional testing was not performed for this complaint.The cause of the reported condition was found to be due to a coiling technique 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: INTERLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9416999
• MDR Text Key: 169307278
• Report Number: 1416980-2019-06710
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• PMA/PMN Number: K993120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C6750H
• Device Lot Number: DR19H14029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1