MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 3 FR X 55 CM; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN036421
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports that the catheter is leaking at the hub where the extension tubing meets the hub.The catheter was replaced.The patient's condition is reported to be fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the customer returned one single-lumen picc and a non-arrow luer attachment for analysis.No signs of use were observed on the catheter body and inside the extension line.The catheter body appeared intentionally severed.Visual inspection of the catheter revealed two small holes on the distal extension line adjacent to the luer hub.The remainder of the extension line was secured inside the luer hub.The catheter body length from the juncture hub to the severed end measured 29.5cm , which is not within the specifications of 55.24cm-55.88cm per product drawing.This indicates that at least 25.74cm of the catheter was severed and not returned.The outer diameter of the distal lumen measured to be 0.08575" which is within specifications of 0.084"-0.088" per product drawing.The inner diameter of the distal lumen measured to be 0.057", which is within specifications of 0.055"-0.059" per product drawing.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." water leaked out of the hole in the distal line.A device history record review was performed with no relevant findings.The instructions for-use (ifu) provided with the kit warns 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 complaint of an extension line leak was confirmed through analysis of the returned sample.There were two holes located on the distal extension line adjacent to the luer hub.The returned sample passed all relevant dimensional inspections.Based on the appearance of the damage, the probable root cause is manufacturing related.A non-conformance has been initiated to further investigate this issue.
Event or Problem Description
Customer reports that the catheter is leaking at the hub where the extension tubing meets the hub.The catheter was replaced.The patient's condition is reported to be fine.

• Brand Name: ARROW PICC KIT: 3 FR X 55 CM
• 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: 17288451
• Report Number: 9680794-2023-00493
• Device Sequence Number: 5642135
• Product Code: LJS
• UDI-Device Identifier: 60801902123420
• UDI-Public: 60801902123420
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K930129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 08/31/2024
• Device Model Number: IPN036421
• Device Catalogue Number: CDC-05531-PK1A
• Device Lot Number: 33F23B0456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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