MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	103401
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation, however, three pictures were provided and visually inspected.It was observed that the venous patient connector was detached from the venous patient line.The reported condition was verified.The cause was attributable to the manufacturing and assembling process.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that, after treatment with a gambro cartridge ext dialyzer, the venous patient connector became detached from the venous blood line.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CARTRIDGE
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12281832
• Report Number: 8030638-2021-00016
• Device Sequence Number: 19770883
• Product Code: FJK
• UDI-Device Identifier: 07332414007867
• UDI-Public: (01)07332414007867(10)
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• PMA/510(K) Number: K070414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2024
• Device Catalogue Number: 103401
• Device Lot Number: 1000287839
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1