MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN030863

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient needed a central catheter and after insertion, the user observed the presence of a tiny hole in the catheter body.The catheter was removed and replaced.There was no consequence for the patient.

Manufacturer Narrative

(b)(4).Customer returned one 3-l cvc catheter and a non-arrow 20ml syringe for investigation.Visual inspection of the catheter did not reveal any defects or anomalies.After the sample failed functional testing (see below), the medial extension line was visually examined.Microscopic examination revealed two slits/holes in the extension line proximal to the juncture hub.The slits/holes appear consistent to when the catheter comes in contact with sharps, such as scissors or scalpel.No other defects or anomalies were observed on the catheter.The overall length of the catheter body measured 166mm which is within specification of 158.5-175mm per product drawing.The outer diameter of the distal extension line measured 2.90 mm which is within specifications of 2.90-3.00 mm per distal extrusion graphic.The inner diameter of the distal extension line measured 2.159 mm which is within specifications of 2.11-2.21 mm per distal extrusion graphic.This indicates that the wall thickness measured within specifications.Functional inspection was performed per the product instructions-for-use (ifu).The ifu provided with this kit states the following: "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the returned catheter had all 3 lumens flushed.The catheter leaked when the medial extension line was flushed.The other extension lines functioned as expected.A manual tug test confirmed that the extension lines were secured to their luer hubs.A device history record review was performed with no relevant findings.The ifu provided with this kit includes the following warnings, cautions and instructions for 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." "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of an extension line leak was confirmed through visual and functional evaluation of the returned sample.The catheter was leaking from two small holes/slits in the medial extension line when injecting water through the lumen.Based on the smooth appearance of the damage, it appears as the extension line was cut by a sharp object such as a scalpel or scissors.A dhr review was completed with no relevant findings.The catheter also passed dimensional inspection.Based on the condition of the returned sample, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The patient needed a central catheter and after insertion, the user observed the presence of a tiny hole in the catheter body.The catheter was removed and replaced.There was no consequence for the patient.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12549042
• MDR Text Key: 273878900
• Report Number: 3006425876-2021-00881
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902000559
• UDI-Public: 10801902000559
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F21B2740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR