MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI PICC 2L: 5FR X 50CM W/ 130CM SS SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35052-HPSL
Medical Device Problem Codes	Complete Blockage (1094); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "new picc was changed to the patient, but my doctor found some difficulty during insertion.The distal port couldn't flush or withdraw after insertion and located at 1/3 of svc.They have tried few times to relocate and flush or withdraw but still fail.At the end doctor removed it and cut the tip of picc then everything goes smoothly without complaint." associated complaint 9680794-2024-00589.
Event or Problem Description
It was reported that: "new picc was changed to the patient, but my doctor found some difficulty during insertion.The distal port couldn't flush or withdraw after insertion and located at 1/3 of svc.They have tried few times to relocate and flush or withdraw but still fail.At the end doctor removed it and cut the tip of picc then everything goes smoothly without complaint." associated complaint 9680794-2024-00589.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for evaluation.The image shows a catheter in use, however, the customer report of a blockage could not be confirmed from the photo.Complete visual analysis could not be performed without the device returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "ensure catheter patency prior to use, including prior to pressure injection." the customer report of a blocked catheter could not be confirmed based on the customer provided photo.The customer image shows a catheter in use, however, the report of a blockage could not be confirmed from the photo.A device history record review 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 monitor and trend for reports of this nature.

• Brand Name: PI PICC 2L: 5FR X 50CM W/ 130CM SS SWG
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19678100
• Report Number: 9680794-2024-00640
• Device Sequence Number: 12503900
• Product Code: LJS
• UDI-Device Identifier: 20801902095521
• UDI-Public: (01)20801902095521(11)240326(17)250731(10)14F24C0210(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K113277
• 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): 06/06/2024

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 Expiration Date: 07/31/2025
• Device Catalogue Number: PR-35052-HPSL
• Device Lot Number: 14F24C0210
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2024
• 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