MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PEDIATRIC JUGULAR SET: 20 GA X 12 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04150
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the guide wire to be faulty.So the md opened up the new kit to finish the procedure." there was no reported patient harm or consequence.The returned device was noted to be separated.
Additional Manufacturer Narrative
Qn# (b)(4).The report that the guide wire separated was confirmed through examination of the returned sample.The core and coil wires were broken near the distal end.The appearance of the separation points is consistent with damage resulting from retracting the guide wire back upon the needle bevel during use.The instructions-for-use (ifu) provided with this kit warns the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring wire guide." no manufacturing defects were found during this investigation.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the difficult advancing the guide wire.Based on these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "during the procedure according to ifu, the md found the guide wire to be faulty.So the md opend up the new kit to finish the procedure." there was no reported patient harm or consequence.The returned device was noted to be separated.

• Brand Name: ARROW PEDIATRIC JUGULAR SET: 20 GA X 12 CM
• Common Device Name: 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18675866
• Report Number: 9680794-2024-00149
• Device Sequence Number: 17698019
• Product Code: DQY
• UDI-Device Identifier: 00801902100535
• UDI-Public: 00801902100535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: ES-04150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female