MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PICC KIT: 2-L 5 FR X 19-5/8" (50 CM); 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	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "dual-lumen picc had to be replaced because it was leaking at the connection site next to the wings where the stat lock would be".As a result, the picc line was replaced.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that "dual-lumen picc had to be replaced because it was leaking at the connection site next to the wings where the stat lock would be".As a result, the picc line was replaced.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen picc for analysis.Signs of use in the form of biological material was observed inside the juncture hub.Initial visual analysis of the returned sample did not reveal any obvious defects or anomalies.Further analysis revealed that proximal extension line easily separated from the juncture hub.Microscopic examination confirmed the damage and revealed that edges were smooth and uniform.It was also observed that the extension line was severed below the proximal lip of the juncture hub.The inner diameter of the proximal extension located within the juncture hub measured 0.058", which is within the specification limits of 0.055"-0.059" per the proximal extension line extrusion product drawing.The inner diameter on the severed line also measured 0.058", which is within the specification limits of 0.055"-0.059" per the proximal extension line extrusion product drawing.The outer diameter on the severed portion of the line measured 0.0945", which is within the specification limits of 0.093"-0.097" per the proximal extension line extrusion product drawing.A lab inventory arrow raulerson syringe filled with water was attached to the distal extension line and flushed.No leaks or blockages were observed as the line flushed as intended.Performed per ifu, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".It was noted that the proximal line was able to flush and exited the point of separation.A manual tug test confirmed the distal line was fully secured within the juncture hub and luer hub.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated for lot# 13c22j0816 to address the issue of an extension line length measuring out of specification.The ifu provided with the kit informs the user, "do not clamp extension line in close proximity of the extension line hub to reduce the risk of component damage".The report of an extension line/juncture hub separation was confirmed through complaint investigation.Visual analysis revealed that the proximal extension line had separated from the juncture hub.A small portion of the extrusion was still inside the juncture hub.Despite the damage, the sample met all relevant dimensional and functional requirements.Based on the customer report and the observed damage, the root cause is likely manufacturing related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: PICC KIT: 2-L 5 FR X 19-5/8" (50 CM)
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18175349
• Report Number: 9680794-2023-00891
• Device Sequence Number: 18064066
• Product Code: LJS
• UDI-Device Identifier: 00801902094568
• UDI-Public: 00801902094568
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 Catalogue Number: ASK-05052-CHC2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/12/2023
• 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
• Patient Sex: Unknown