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

Catalog Number JC8723

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported that a large hole was discovered in the tubing of a clearlink system y-type blood/solution set.The issue was identified during setup and preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

D4: expiration date: 12/26.H10: the device was received for evaluation.Visual inspection observed a hole in the tubing.The device failed pressure testing and clear passage testing.The reported condition was verified.The cause of the condition was due to incorrect placement of the set in the pouch during manufacturing, leaving part of the set outside the pouch and exposed to the packaging machine¿s blades.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: CLEARLINK BLOOD RECIPIENT SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15230017
• MDR Text Key: 302082656
• Report Number: 1416980-2022-04223
• Device Sequence Number: 1
• Product Code: BRZ
• UDI-Device Identifier: 00085412152776
• UDI-Public: (01)00085412152776
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: JC8723
• Device Lot Number: R22A23123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1