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

Catalog Number JC7751

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the glue at the spike of a y-type blood/soln set was separated from the tubing.This was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6.Correction to d4: unique identifier (udi) #.H10: the actual sample was received for evaluation.Visual inspection performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing; the device performed according to product specifications.An additional pull test was performed with no issues noted.The reported condition was not verified.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: BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10383032
• MDR Text Key: 202166926
• Report Number: 1416980-2020-04824
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC7751
• Device Lot Number: DR19G18030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1