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

Catalog Number JC7751

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a y-type blood/soln set leaked.¿after spiking product and releasing the roller clamp to run wide open,¿ fluid was observed on the tubing.Upon further inspection, a ¿tear was noted on the tubing at point where roller clamp had previously been engaged¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3, h4 and h6.Correction to d4: lot # and f10/h6: device codes (missing code for tear; add 4008).D4: lot # was either dr20e17025 or dr20a16067.H4: the suspected lot # dr20e17025 was manufactured on 05/18/2020.The suspected lot # dr20a16067 was manufactured on 01/17/2020.H10: the device was received for evaluation.Visual inspection was performed; all components were correctly placed and according to specifications.However, a hole on the tubing was identified which would result in a leak.The reported condition was verified.The cause of the hole could not be determined.A batch review was conducted for both lots and there were no deviations found related to this reported condition during the manufacture of these lots.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: 10970734
• MDR Text Key: 220676290
• Report Number: 1416980-2020-07642
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC7751
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1