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

Catalog Number JC7751

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that drip chamber of a y-type blood/soln set had hair.This was identified prior to patient use.The blood tubing was hung and primed with normal saline to be used for packed red blood cells (prbc) transfusion.Once primed, the hair was noted in the drip chamber.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection on the received device did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to product specifications; however, a hair was observed inside the bottom cap of the blood filter chamber.The reported condition was verified.The cause of the condition is manufacturing issue.Additionally, a functional testing was performed including clear passage and pressure testing; and the device performed according to product specifications.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: 10511408
• MDR Text Key: 206300247
• Report Number: 1416980-2020-05580
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152738
• UDI-Public: (01)00085412152738
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• 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: DR19E17044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1