MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number IPN919796

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Migration (4003)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the line was stitched in - it slipped through the holder , (associated to this complaint) happened twice on 1 patient, there was a previous issue the week before , (associated to 2 other complaints tc# (b)(4)) - unwell lady with high inotrope requirements leading to a delay in continuing her cvvhd - the line was promptly replaced.The patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.

Event Description

It was reported that: the line was stitched in - it slipped through the holder, (associated to this complaint) happened twice on 1 patient, there was a previous issue the week before, (associated to 2 other complaints tc# (b)(4) and tc# (b)(4)) - unwell lady with high inotrope requirements leading to a delay in continuing her cvvhd - the line was promptly replaced.The patient's condition did not deteriorate due to immediate replacement of line, the patient was not harmed.

Manufacturer Narrative

Qn# (b)(4).Additional information from the account: the catheter was secured to the patients skin via the plastic holder which was sutured via 2 holes to the patient skin, the catheter is free to rotate but it slipped out of the holder.The customer provided two photos for evaluation.The complaint of a catheter migration was able to be confirmed by the photos.The photos show the suture wing clip separated from the catheter body with the wing clip sutured to the patient.The customer also returned one acute hemodialysis catheter for analysis.Sings of use in the form of biological material was observed.Visual analysis revealed that the catheter was returned with the wing clip secure to the catheter juncture hub.No obvious visual defects or anomalies were observed with the juncture hub nor the wing clip.The inner diameter of the wing clip measured 0.242", which is not within the specification limits of 0.228"-0.238" per the wing clip graphic; however, confirmation from the manufacturing facility revealed that this likely occurred as a result of the suture wing being forcefully removed from the juncture hub.Undue force was required to remove the wing clip from the catheter body of the returned sample.The wing clip was removed and reinserted back over the juncture hub.Once in place, the wing clip appeared fixed and could not be easily removed.Performed, per ifu statement, "position suture wing around the catheter body adjacent to the venipuncture site".Manufacturing engineers have been previously contacted regarding complaints of this nature.They have indicated that wing clip separation can be caused by applying undue force to the catheter assembly.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the customer report of a catheter migration was confirmed through complaint investigation of the returned sample.Visual inspection of the customer photo revealed the catheter wing clip separated from the juncture hub.The catheter was returned with the wing clip secure to the hub, and undue force was required to remove the clip.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17955701
• MDR Text Key: 325934349
• Report Number: 3006425876-2023-00984
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100221
• UDI-Public: 00801902100221
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN919796
• Device Catalogue Number: CS-25142-F
• Device Lot Number: 71F23F0934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 80 KG