MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM; CATEHTER HEMODIALYSIS NON IMPL

Catalog Number	CU-23122-F
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the doctor found the dilator tip damaged during used on the patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.The customer returned one dilator, a catheter-over-needle assembly, and an 18ga introducer needle for analysis.Signs of use were observed on the returned components.Visual inspection of the dilator revealed the tip was deformed.In addition, there appeared to be a clear substance within the distal tip of the dilator.The damage to the dilator tip is consistent with undue force applied on the dilator during an attempted insertion.The dilator body length measurement was within specification and the dilator inner diameter at the distal tip could not be accurately measured due to the nature of the damage.The dilator met all relevant functional requirements, and a device history record review was performed with no relevant findings.Based on the sample received, comments from manufacturing, and the report that the defect was found during use, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the doctor found the dilator tip damaged during used on the patient." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 13 CM
• Common Device Name: CATEHTER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18978008
• Report Number: 3006425876-2024-00286
• Device Sequence Number: 20492752
• Product Code: MPB
• UDI-Device Identifier: 00801902100269
• UDI-Public: 00801902100269
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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 Expiration Date: 04/25/2025
• Device Catalogue Number: CU-23122-F
• Device Lot Number: 71F23L0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown