MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number CDA-42703-XPCN1A

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "product catheter was introducing air when pulling back with a syringe".The catheter was removed and a new line was placed.No patient harm or injury.Patient current condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer returned one, 3-lumen cvc for analysis.Signs of use in the form of biological material were observed inside the catheter body.Visual analysis revealed that the proximal extension line contained a hole around the middle of the extrusion.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The appearance of the damage is consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).The hole on the proximal line measured 115mm from the luer hub (white).The proximal line outer diameter measured 0.085", which is within the specification limits of 0.084"-0.088" per the proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 0.056", which is within the specification limits of 0.055"-0.059" per the proximal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.When flushing the proximal line, water was observed leaking from the hole.No leaks were detected when flushing the medial or distal lines.Performed per ifu statement, "flush lumen(s) to completely clear blood from catheter".The ifu provided with the kit informs 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 report of a leaking extension line was confirmed through complaint investigation.Visual and functional analysis revealed a hole on the proximal extension line.The edges of this hole appear smooth, uniform and consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpel, etc.).Despite the damage, the sample met all relevant dimensional requirements.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "product catheter was introducing air when pulling back with a syringe".The catheter was removed and a new line was placed.No patient harm or injury.Patient current condition reported as "fine".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• 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: 18627224
• MDR Text Key: 334355410
• Report Number: 9680794-2024-00074
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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 Operator: Health Professional
• Device Catalogue Number: CDA-42703-XPCN1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED