MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05052-LW
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that " when dr.Inserted picc catheter line into patient's vessel, he found that the hub slipped out from the catheter.They solved the problem by removing the defected one and replacing with a new one.There was a delay in the procedure but there was no reported patient harm or consequence.They were reported as fine post the procedure.
Additional Manufacturer Narrative
(b)(4), the report of a catheter body separation was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was separated from inside the juncture hub.The hub was cross-sectioned, and a small portion of the catheter body was molded inside.A device history record review was performed, and no relevant findings were identified.A small hole was noted on the juncture hub.This small hole is located directly adjacent to the point of separation from inside the juncture hub.Therefore, it is likely that this hole contributed to the separation on the catheter body.Based on the customer report and the sample received, manufacturing caused or contributed to this event.An investigation was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " when dr.Inserted picc catheter line into patient's vessel, he found that the hub slipped out from the catheter.They solved the problem by removing the defected one and replacing with a new one.There was a delay in the procedure but there was no reported patient harm or consequence.They were reported as fine post the procedure.

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 18245851
• Report Number: 9680794-2023-00948
• Device Sequence Number: 15124740
• Product Code: LJS
• UDI-Device Identifier: 50801902095393
• UDI-Public: 50801902095393
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K073451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 04/30/2025
• Device Catalogue Number: PR-05052-LW
• Device Lot Number: 14F23D0194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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