MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAP

Model Number	IPN032988
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: central line was leaking at the extension line.No patient injury or harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: central line was leaking at the extension line.No patient injury or harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 3-lumen pi cvc for evaluation.The catheter contained obvious signs of use in the form of biological material.Visual examination of the catheter did not reveal any defects or anomalies.No kinks, holes, or cuts were observed.The total length of the catheter measured to be 214 mm which is within specifications of 207-227 mm per product drawing.The inner diameter of the medial lumen measured to be 0.057" which is within specifications of 0.055"-0.059" per product drawing.The outer diameter of the medial lumen measured to be 0.084" which is within specifications of 0.084"-0.088" per product drawing.This indicates that the wall thickness measured within specifications.The inner diameter of the proximal lumen measured to be 0.057" which is within specifications of 0.055"-0.059" per product drawing.The outer diameter of the proximal lumen measured to be 0.084" which is within specifications of 0.084"-0.088" per product drawing.This indicates that the wall thickness measured within specifications.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 outer diameter of the distal lumen measured to be 0.084" which is within specifications of 0.084"-0.088" per product drawing.This indicates that the wall thickness measured within specifications.Functional inspection was performed to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile saline solution to establish patency and prime lumen(s)." all three extension lines of the returned catheter were tested for liquid leakage per amrq-000071 rev.12 (bs en iso 10555-1 annex c) which states that no liquid leakage should form in one or more falling drops of water when tested at 300kpa for 30 seconds.The catheter was attached to the leak tester the distal end was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks were detected from any region of the catheter, including the extension lines; therefore, the sample passed functional testing.A manual tug test confirmed all three extension lines were fully secured within their respective hubs.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit cautions 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." the customer report of an extension line leak could not be confirmed by complaint investigation of the returned sample.The catheter passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11542915
• Report Number: 9680794-2021-00115
• Device Sequence Number: 19967889
• Product Code: FOZ
• UDI-Device Identifier: 00801902099471
• UDI-Public: 00801902099471
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: No Information
• Device Expiration Date: 10/31/2022
• Device Model Number: IPN032988
• Device Catalogue Number: CDA-45703-P1A
• Device Lot Number: 13F20M0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED