MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX40CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-34041-HPHNM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "leaked from the junction of the hub and the catheter during use, and the patient had no safety concerns." the device was removed and replaced.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "leaked from the junction of the hub and the catheter during use, and the patient had no safety concerns." the device was removed and replaced.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).Section d.4.Unique identifier (udi)# corrected from (b)(4) to (b)(4).The customer returned one single-lumen picc for analysis.Signs of use were observed on the catheter.Visual analysis of the catheter revealed a hole on the extension line adjacent to the distal luer hub.The remainder of the extension line was secured inside the luer hub.The catheter body length from the juncture hub to the severed end measured 15 15/16", which is within the specification of 15 5/8"-16 1/8" per product drawing.The outer diameter (od) of the distal lumen measured to be 0.0935", which is within specifications of 0.0930"- 0.0970" per product drawing.The inner diameter (id) of the distal lumen measured to be 0.057", which is within specifications of 0.055"-0.059" per product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The catheter was flushed with lab inventory ars, and leaking observed at the location of the distal luer hub.A manual tug test confirmed the distal extension line was still secured to its luer hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The customer report of an extension line leak was confirmed through complaint investigation of the returned sample.Visual inspection revealed a hole in the distal extension line adjacent to the luer hub.The appearance of the damage is consistent with a molding defect.Based on these circumstances, manufacturing likely caused or contributed to this event.Non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI PICC 1L 4FRX40CM W/80CM HYDRO NIT 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19482388
• Report Number: 9680794-2024-00541
• Device Sequence Number: 18226793
• Product Code: LJS
• UDI-Device Identifier: 00801902100931
• UDI-Public: 00801902100931
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 11/30/2024
• Device Catalogue Number: PR-34041-HPHNM
• Device Lot Number: 13F22M0079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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 Sex: Unknown