MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 1L 4FRX50CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35041-HPHNM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
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.The patient's current condition reported "fine".
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.The patient's current condition reported "fine".
Additional Manufacturer Narrative
(b)(4).Section d.4.Unique identifier (udi)# corrected to (b)(4).The customer returned one s-l picc for evaluation.Signs-of-use were observed on the returned device.The catheter appeared intentionally severed.Visual inspection revealed a hole adjacent to the distal luer hub.The catheter body length measure 19" which is not within the specifications of 19 1/2"-20" per product drawing.This indicates that at least 1/2" of the catheter was severed and not re-turned for analysis.The distal extension line outer diameter (od) measured 0.09320" which is within the specifications of 0.093"-0.097" per product drawing.The distal extension line inner diameter (id) measured 0.057" which is within the specifications of 0.055"-0.059" per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter was flushed using a lab inventory 10ml syringe.Water was observed exiting the hole in the distal extension line.A device history record review was performed, and two findings were identified.Nonconformances were initiated to address the issue of a deformed catheter body.Based on evaluation of the returned sample, these are not relevant to the reported issue.The ifu provided with the kit in-forms 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 adjacent to the distal luer hub.The appearance of the damage is consistent with a manufacturing issue.The catheter met all relevant dimensional and functional requirements.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 4FRX50CM 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: 19477345
• Report Number: 9680794-2024-00531
• Device Sequence Number: 7071985
• Product Code: LJS
• UDI-Device Identifier: 00801902101051
• UDI-Public: 00801902101051
• 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-35041-HPHNM
• Device Lot Number: 13F22M0076
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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