MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, HEMODIALYSIS, NON-I

Model Number IPN919946

Device Problems Disconnection (1171); Mechanical Problem (1384)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: we had to connect a plasma exchange line to a patient with a right internal jugular dialysis catheter.The line was clamped and had caps at both ends.After removing the caps, we noticed that a clamp had opened.We immediately reclamped the clamp and aspirated the contents of the line.There was no trace of air, no air found.The doctor was immediately informed, no signs of distress were observed and the ultrasound performed by the medical team showed no abnormality.The device is still inserted in the patient at the time of logging.

Manufacturer Narrative

(b)(4).The customer returned one, 2-lumen acute hemodialysis catheter for analysis.Signs of use in the form of biological material were observed on the catheter body.It was observed that the catheter body was severed.The severed end was not returned for analysis.It is being assumed that the customer intentionally severed the body during usage of the device.Visual analysis of the returned catheter did not reveal any defects or anomalies of any kind.The pinch clamps did not show any deformities and were correctly positioned on the extension lines.After performing functional testing, it was noted that both clamps were able to lock as intended.They appeared secure and successfully occluded both extension lines.Both pinch clamps were locked onto the respective extension line.No obvious issues were observed as both clamps were able to lock with little to no issue.After locking, the clamps felt secure and would not unlock when manipulating.Performed per ifu statement , "pinch clamp(s) are provided on extension lines to occlude flow through each lumen during line and luer-lock connector changes".A lab inventory syringe filled with water was then attached to both extension lines.With the pinch clamps activated, the lines were pressurized.The clamps appeared to fully occlude both extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "connect all extension line(s) to appropriate luer-lock connector(s) as required.Unused port(s) may be 'locked' through luer-lock connector(s) using standard institutional policies and procedures".The ifu also states, "open pinch clamp prior to infusion through lumen to reduce risk ofdamage to extension line from excessive pressure".The report that the pinch clamps do not lock was not able to be confirmed through complaint investigation.The returned clamps met all relevant visual and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: we had to connect a plasma exchange line to a patient with a right internal jugular dialysis catheter.The line was clamped and had caps at both ends.After removing the caps, we noticed that a clamp had opened.We immediately reclamped the clamp and aspirated the contents of the line.There was no trace of air, no air found.The doctor was immediately informed, no signs of distress were observed and the ultrasound performed by the medical team showed no abnormality.The device is still inserted in the patient at the time of logging.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• 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: 18299886
• MDR Text Key: 330114503
• Report Number: 3006425876-2023-01219
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10801902029215
• UDI-Public: 10801902029215
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

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 Model Number: IPN919946
• Device Catalogue Number: CV-12142-UF
• Device Lot Number: 71F23B1442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2023
• 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