MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-L 15 FR X 23 CM; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	CSD-15282-SP
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the sheath will not peel apart and the doctors are having to pull it out and cut it just to get it out.We completed the case and placed the cannon catheter they just had to cut the sheath and do some pulling and pushing to get it placed.The patient did well during and after the procedure it just took more time and added some frustration to the doctor." associated complaints: 9680794-2024-00492, and 9680794-2024-00493.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and potentially relevant findings were identified.There are multiple events related to the same material of c-70013-003 and failure mode of "peel-away sheath tears incorrectly".It cannot be confirmed whether this finding is relevant to the reported event without the sample being returned for analysis.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.
Event or Problem Description
It was reported that: "the sheath will not peel apart and the doctors are having to pull it out and cut it just to get it out.We completed the case and placed the cannon catheter they just had to cut the sheath and do some pulling and pushing to get it placed.The patient did well during and after the procedure it just took more time and added some frustration to the doctor." associated complaints: 9680794-2024-00492, 9680794-2024-00493 and 9680794-2024-00491.

• Brand Name: HEMODIALYSIS SET: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19257586
• Report Number: 9680794-2024-00491
• Device Sequence Number: 12377865
• Product Code: MSD
• UDI-Device Identifier: 20801902096634
• UDI-Public: 20801902096634
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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: CSD-15282-SP
• Device Lot Number: 33F24A0297
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown