MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPRING WIRE GUIDE COMPONENT; WIRE, GUIDE, CATHETER

Catalog Number	PW-18130
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that: "a guide wire broke in the basilic".Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4).Additional information received 22-may-2024 indicates the patient experienced no symptoms during the event, and the patient condition was "fine" at the end of the intervention.It was reported that "this picc was planned and install because this patient was already scheduled to received medical assisted death (which he received 2 days later)".It was also reported that "the part was not in the basilic vein it was outside and under the skin it was decided to leave it there".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 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.Corrected data: section d.4.- unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that: "a guide wire broke in the basilic".

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19321294
• Report Number: 9680794-2024-00526
• Device Sequence Number: 7592650
• Product Code: DQX
• UDI-Device Identifier: 10801902101485
• UDI-Public: 10801902101485
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011084
• 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): 05/09/2024

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
• Device Catalogue Number: PW-18130
• Device Lot Number: 14F23H0046
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown