MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN922683
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: anesthesia placed central line on patient's ij.After having sutured in line, anesthesia resident noticed blood coming out of the tubing of the central line, as if it had been penetrated by a needle.Both the anesthesiologist and anesthesia resident agreed that a needle never came in contact with the surface of the tubing during insertion and came to the conclusion that the tubing was defective.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: anesthesia placed central line on patient's ij.After having sutured in line, anesthesia resident noticed blood coming out of the tubing of the central line, as if it had been penetrated by a needle.Both the anesthesiologist and anesthesia resident agreed that a needle never came in contact with the surface of the tubing during insertion and came to the conclusion that the tubing was defective.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one 4-l catheter and the product insert for analysis.Initial visual inspection of the catheter showed no defects or anomalies.After the catheter failed functional testing (see below), the catheter body was further inspected to determine the source of the leak.A small cut was observed on the catheter body, adjacent to the juncture hub.The appearance of the damage is consistent with contact with a sharp instrument (i.E.Scalpel, scissors, etc).The total length of the catheter body measured 216 mm which is within specifications of 207-227 mm per product drawing.The catheter body outer diameter measured 2.90mm, which is within the specification of 2.87 - 2.97 mm per product drawing.Functional inspection was performed on the returned catheter to recreate the product's intended use.The ifu provided with this kit states: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)" all extension lines flushed as expected.The extension lines 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.Each extension line was separately attached to the leak tester, the distal tip of the catheter was occluded, and the leak tester was turned to 300 kpa for 30 seconds.When testing the catheter, a small leak was found coming from the catheter body near the juncture hub.A manual tug test confirmed the extension lines were fully secured within their respective hubs.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit states, "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 customer report of an extension line leak was confirmed by complaint investigation of the returned sample.During functional leak testing performed per bs en iso 10555-1, a leak was found from the catheter body.Visual inspection revealed a small hole in the catheter body near the juncture hub, which is consistent with damage caused by unintentional contact with sharps.A device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error is the probable root cause for this complaint.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13402855
• Report Number: 9680794-2022-00040
• Device Sequence Number: 11976400
• Product Code: FOZ
• UDI-Device Identifier: 10801902202557
• UDI-Public: 10801902202557
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 01/10/2022

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: 03/31/2023
• Device Model Number: IPN922683
• Device Catalogue Number: ASK-45854-BJC1
• Device Lot Number: 13F21H0279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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