MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER PERCUTANEOUS

Model Number IPN030757

Device Problem Obstruction of Flow (2423)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

Customer reported some lumens of the cvc were obstructed and couldn't be used.It first occurred with the blue lumen, where sedation with dormicum and sufenta and ringer's was administered at a flow of at least 10 ml/hr up to 42 ml/hr.The grey medial lumen was also occluded.The occlusion alarm sounded several times and it was possible to irrigate against resistance, but suddenly this was no longer possible.There was no patient injury.Another lumen was used.It was reported the cvc was cut open and there was a large blood clot in the system.It was reported the patient was on ventilation with covid at the time of this report.

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer returned a representative sealed cvc kit for analysis with various components, including a 4-l catheter.Visual analysis revealed did not reveal any defects or anomalies on the returned catheter or any other components.The catheter body from the juncture hub to the distal tip measured 170mm which is within the specification limits of 157-177mm per the catheter graphic.The catheter body outer diameter measured 2.92 mm which is within the specification limits of 2.87-2.97mm per the catheter extrusion graphic.A lab inventory syringe filled with water was attached to both extension lines and aspirated.No blockages or leaks were observed as the water exited out of the normal locations on the catheter body.Performed per ifu statement "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a manual tug test confirmed that all extension lines were secure within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the report of a blocked catheter could not be confirmed through complaint investigation.Visual and functional analysis of the returned representative sample did not reveal any blockages or leaks.Additionally , the catheter met all relevant dimensional 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.The root cause could not be determined without the actual complaint sample returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported some lumens of the cvc were obstructed and couldn't be used.It first occurred with the blue lumen, where sedation with dormicum and sufenta and ringer's was administered at a flow of at least 10 ml/hr up to 42 ml/hr.The grey medial lumen was also occluded.The occlusion alarm sounded several times and it was possible to irrigate against resistance, but suddenly this was no longer possible.There was no patient injury.Another lumen was used.It was reported the cvc was cut open and there was a large blood clot in the system.It was reported the patient was on ventilation with covid at the time of this report.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13388623
• MDR Text Key: 285351513
• Report Number: 3006425876-2022-00090
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902028980
• UDI-Public: 10801902028980
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K862056
• 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
• Report Date: 01/06/2022

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 Model Number: IPN030757
• Device Catalogue Number: CS-12854-E
• Device Lot Number: 71F20M0505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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: DORMICUM, SUFENTA, RINGER'S; DORMICUM, SUFENTA, RINGER'S