MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L: 5FR X 40CM W/ 130CM SS SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	ASK-05052-CHC2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The picc was reported as leaking "at the end of the picc in the area before the line is connected".The catheter was inserted on (b)(6) 2023.Picc was removed and replaced with a different picc exchanged over a wire.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of an extension line leak was confirmed through investigation of the returned sample.Leaking was observed from where the proximal extension line met the luer hub.Based on the appearance of the damage, the probable root cause is manufacturing related.A device history record review was performed, and no relevant findings were identified.An investigation was initiated to further investigate the issue.The investigation is still on-going.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
The picc was reported as leaking "at the end of the picc in the area before the line is connected".The catheter was inserted on (b)(6) 2023.Picc was removed and replaced with a different picc exchanged over a wire.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI PICC 2L: 5FR X 40CM 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18004175
• Report Number: 9680794-2023-00801
• Device Sequence Number: 20742783
• Product Code: LJS
• UDI-Device Identifier: 10801902095463
• UDI-Public: 10801902095463
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 09/30/2024
• Device Catalogue Number: ASK-05052-CHC2
• Device Lot Number: 33F23E0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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