MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15232-X
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the screw thread was defective and the dilator's non-return valve was dysfunctional".The current condition of the patient is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Associated mdr number: 9680794-2024-00049.
Event or Problem Description
It was reported "the screw thread was defective and the dilator's non-return valve was dysfunctional".The current condition of the patient is "unknown".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Associated mdr number: 9680794-2024-00049.
Additional Manufacturer Narrative
Qn#(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "warning: green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18629618
• Report Number: 9680794-2024-00050
• Device Sequence Number: 18131299
• Product Code: MSD
• UDI-Device Identifier: 00801902096302
• UDI-Public: 00801902096302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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 Catalogue Number: CS-15232-X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown