MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATHETERIZATION KIT; CATHETER, PERCUTANEOUS

Catalog Number ASK-01218-HM

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "bent ra-04020 inside kit".This was found prior to use.No patient involvement.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and a potential finding was identified; however, without the device returned for evaluation it cannot be determined if this finding is relevant to the customer reported issue.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.If the sample becomes available at a later date , a follow up report will be submitted with investigation results.

Event Description

It was reported "bent ra-04020 inside kit".This was found prior to use.No patient involvement.

• Brand Name: ARROW ARTERIAL CATHETERIZATION KIT
• Type of Device: CATHETER, PERCUTANEOUS
• 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19215054
• MDR Text Key: 341469235
• Report Number: 9680794-2024-00343
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902217049
• UDI-Public: 10801902217049
• Combination Product (y/n): N
• PMA/PMN Number: K171146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-01218-HM
• Device Lot Number: 33F23L0166
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2023
• 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
• Treatment: NONE REPORTED; NONE REPORTED