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
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after catheter insertion, its position was verified by x-rays, revealing catheter looping in the subclavian vein.Attempts were made twice to reposition the catheter without success.Subsequently, the decision was made to completely remove the catheter and repeat the procedure with a new device.This time, the procedure was performed without complications, resulting in the insertion of a 5fr double lumen picc catheter in the basilic vein of the right upper limb." no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of catheter bending was confirmed by visual inspection of the customer supplied photo.The customer photo shows the picc catheter entering through the right basilic vein and mov-ing upwards instead of downwards towards the svc.The customer description suggests the selected vein may have been too torturous for the picc to drop into the svc which is a common occurrence depending on the patient's vasculature and health background.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record re-view was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to moni-tor and trend for reports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected to (b)(t).
Event or Problem Description
It was reported "after catheter insertion, its position was verified by x-rays, revealing catheter looping in the subclavian vein.Attempts were made twice to reposition the catheter without success.Subsequently, the decision was made to completely remove the catheter and repeat the procedure with a new device.This time, the procedure was performed without complications, resulting in the insertion of a 5fr double lumen picc catheter in the basilic vein of the right upper limb." no patietn harm or injury.The patient's current condition is reported as "fine".

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19444872
• Report Number: 9680794-2024-00514
• Device Sequence Number: 20974178
• Product Code: LJS
• UDI-Device Identifier: 10801902095371
• UDI-Public: 10801902095371
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: PR-05052
• Device Lot Number: 14F23J0238
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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 Age: 62 YR
• Patient Sex: Male