MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45552-TTS
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the tip tracker stylet separated from the stereojack connector following unsuccessful picc placement.Wire is noted to have a deformity and was very difficult to remove from the picc prior to separation.Additional information: the issue was identified during use.No medical intervention was needed and the patient did not experience any signs or symptoms.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).One k-01351-051 stylet:.015" dia x 29" and one mc-45552-003c coated cath 2-l: 5.5 fr x 21-21/32" 55cm coated catheter were returned.A visual examination of the stylet revealed the stylet wires are separated from the stylet housing and the t-port extension.Using calibrated ruler, kinks were observed approximately 8 3/4, 22 1/4, and 28 inches from the stylet distal tip.A visual examination of the catheter revealed the catheter was trimmed to 46 cm with no other obvious defects or anomalies observed.The overall length of the returned stylet wires measured approximately 30 1/8 inches, which meets the specifications of.015" x 29".No part of the original wires were observed to be missing.It was reported "the tip tracker stylet separated from the stereo jack connector following unsuccessful picc placement.Wire is noted to have deformity and was very difficult to remove from the picc prior to separation".Photographs were provided by the complainant.Picture 1 shows the ecg wire and the coil wire are missing from the stylet housing and t-port connector.Picture 2 shows a view of the t-port connector without a stylet.During functional testing, the returned stylet was threaded through and removed from the returned catheter with no issues observed.A known good stylet was threaded through and removed from the returned catheter with no issues observed.No issues were observed with the returned catheter.The coil wire has been broken and is no longer in the housing and the core wire was soldered in the housing at one time but the core wire is no longer in the housing.The polyimide tubing has been abraded for approximately 1 inch starting at approximately 2 1/2 inches from the stylet housing.The abrasion results in exposing the core wire and coil wire, but they remain intact.The abrasion is located well above the luer fittings and that part of the stylet was most likely not in the catheter at any time.The abrasion most likely occurred during attempts to remove the stylet from the catheter.The white polyurethane strain relief is secured to the housing.The results of the functional inspection suggests the user unintentionally subjected the stylet to a force which defeated the strain relief where the stylet exits the stylet housing.A device history record review performed on the stylet did not reveal any manufacturing related issues.The report "wire is noted to have deformity" was confirmed by the existence of the kinks and the abrasion of the stylet.The report "tip tracker stylet separated from the stereo jack connector" was confirmed by visual evaluation.A device history record review performed on the stylet did not reveal any manufacturing related issues.The findings of this investigation suggests the user unintentionally subjected the stylet to a force which defeated the strain relief where the stylet exits the stylet housing.No further action will be taken.
Event or Problem Description
It was reported that: the tip tracker stylet separated from the stereojack connector following unsuccessful picc placement.Wire is noted to have a deformity and was very difficult to remove from the picc prior to separation.Additional information: the issue was identified during use.No medical intervention was needed and the patient did not experience any signs or symptoms.

• Brand Name: ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPT
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 18140412
• Report Number: 9680794-2023-00886
• Device Sequence Number: 12409190
• Product Code: LJS
• UDI-Device Identifier: 30801902125386
• UDI-Public: 30801902125386
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/18/2023

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 Expiration Date: 09/12/2024
• Device Catalogue Number: CDC-45552-TTS
• Device Lot Number: 33F23G0522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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