MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L: 5FR X 40CM W/ 130CM SS SWG; 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	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The dual-lumen picc has been reported to leak where the two ports split.The catheter was placed on (b)(6) 2023.Picc was removed and replaced with a different picc with an over the wire exchange.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The dual-lumen picc has been reported to leak where the two ports split.The catheter was placed on (b)(6) 2023.Picc was removed and replaced with a different picc with an over the wire exchange.The patient's condition 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 were observed.It was noted that the catheter body was severed at the 50cm marking.Visual analysis revealed that the proximal extension line had separated from the juncture hub.A portion of the extrusion was still molded within the juncture hub.The separated extension line was not returned for analysis.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 0.057", which is within the specification limits of 0.055"-0.059" per the proximal extension line extrusion product drawing.The proximal extension line outer diameter could not be accurately measured as it was located within the juncture hub.Dimensional analysis could not be performed on the rest of the severed extension line as it was not returned.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)".Functional analysis could not be performed on the proximal line as it was not returned.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 no relevant findings were identified.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, and a device history record review did not reveal any relevant findings.Based on the customer report and the observed damage, the probable root cause is 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: ARROW PI PICC 2L: 5FR X 40CM W/ 130CM SS 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18003804
• Report Number: 9680794-2023-00803
• Device Sequence Number: 6538911
• Product Code: LJS
• UDI-Device Identifier: 10801902095463
• UDI-Public: 10801902095463
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: ASK-05052-CHC2
• Device Lot Number: 13F22L0366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown