MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-35052-VPS
Medical Device Problem Codes	Difficult to Flush (1251); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: the picc stopped drawing blood and stopped flushing.The issue was identified during use on patient.There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l picc for analysis.Signs of use were observed on the catheter body and inside the extension lines.The catheter body was observed to be intentionally severed at the distal tip.Visual inspection of the catheter revealed no obvious defects or anomalies.The length of the catheter body from the juncture hub to the severed end measured 14 1/2" which is not within the specifications of 19 1/2" - 20" per product drawing.This indicates that at least 5" of the catheter were severed and not returned for analysis.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen." the distal and proximal lumens of the catheter were flushed using a lab inventory 10ml syringe.The extension lines flushed normally.No leaks or blockages were observed.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit warns the user, "ensure catheter patency prior to use, including priorto pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter.Minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the customer report of a blocked catheter could not be confirmed through complaint investigation of the returned sample.Visual inspection revealed no obvious defects or anomalies.The returned catheter met all relevant functional requirements, with no blockages observed.A device history record review based on sales history was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: the picc stopped drawing blood and stopped flushing.The issue was identified during use on patient.There was no reported patient harm or consequence.

• Brand Name: ARROW PI PICC:2L 5FR X 50CM PRELOAD VPS STYLET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18056680
• Report Number: 9680794-2023-00820
• Device Sequence Number: 17660785
• Product Code: LJS
• UDI-Device Identifier: 80801902123745
• UDI-Public: 80801902123745
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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
• Device Catalogue Number: CDC-35052-VPS
• Device Lot Number: 13F23A042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Patient Sex: Unknown