MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW THORACENTESIS KIT; CATHETER AND TIP SUCTION

Catalog Number AK-01000-J

Device Problem Material Deformation (2976)

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

Event Date 12/19/2022

Event Type  malfunction  

Event Description

It was reported that: "introducer sheath broke on insertion of needle - when inserting needle for procedure." another device used to complete procedure.Patient condition reported as "fine.".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The complaint of catheter tip damaged/defective was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone , and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that: "introducer sheath broke on insertion of needle - when inserting needle for procedure." another device used to complete procedure.Patient condition reported as "fine".

Event Description

It was reported that: "introducer sheath broke on insertion of needle, when inserting needle for procedure." another device used to complete procedure.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer provided one image showing a thoracentesis assembly for analysis.Visual analysis revealed that the catheter tip was punctured by the needle bevel.The customer also returned one thoracentesis catheter assembly for analysis.Signs of use were observed.Visual analysis revealed that the needle bevel had punctured the catheter body.Microscopic examination confirmed the damage.The total catheter length measured approximately 149mm (5.86") which equals the nominal value of 5.86" per the thoracentesis device product drawing.The catheter body outer diameter measured 0.104", which is within the specification limits of 0.104"-0.106" per the catheter extrusion product drawing.The needle cannula outer diameter measured 0.0500", which is within the specification limits of 0.0495"-0.0505" per the cannula product drawing.The cannula inner diameter at the distal and proximal ends measured 0.033", which is within the specification limits of 0.0315"-0.0345" per the cannula product drawing.The needle was removed from the catheter with little to no resistance.The needle was then carefully reinserted.The bevel exited through the damage on the catheter body.Performed per ifu statement , "advance catheter 1-1/2" (3.8 cm) or until black marking band (where provided) is not visible to ensure that all drainage holes are inside chest wall".The manufacturing facility was contacted as part of this complaint investigation.After assembly of catheter to the needle, the operator will verify that the distance between needle tip and catheter tip is within the specified range.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "introducer needle must not be advanced back into catheter after it has been partially withdrawn".The report of a catheter tip damaged was confirmed through complaint investigation.Visual analysis revealed that the bevel of the needle cannula had punctured the catheter body directly adjacent to the tip.Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report that the damage was observed during use and the appearance of the damage, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW THORACENTESIS KIT
• Type of Device: CATHETER AND TIP SUCTION
• 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: 16121144
• MDR Text Key: 308103000
• Report Number: 9680794-2023-00017
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K870572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AK-01000-J
• Device Lot Number: 13F22C0914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• 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; NONE REPORTED