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  

Manufacturer Narrative

Qn# (b)(4).

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.

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

(b)(4).The customer returned one, unopened cvc kit for analysis.It is being assumed that this is a representative sample.The seal was completely intact around the entire kit.The kit was opened to analyze the kit contents.Visual analysis of the catheter did not reveal any defects or anomalies.Visual analysis could not be performed on the actual catheter involved with this complaint as it was not returned.The length of the returned catheter measured 170mm which is within the specification limits of 157mm-177mm per the catheter graphic.The catheter body outer diameter measured 2.87mm which is within the specification limits of 2.87mm-2.97mm per the catheter extrusion graphic.The ifu provided with the kit informs the user, "ensure catheter patency prior to use".All four of the catheter lumens were flushed with a lab inventory syringe.No defects or anomalies were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs 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".The report of a blocked catheter was not able to be confirmed through complaint investigation.Visual analysis revealed that the customer returned one representative sample for analysis.All relevant dimensional and functional requirements were met, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause cannot be determined at this time without the actual complaint sample returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 13387757
• MDR Text Key: 285012751
• Report Number: 3006425876-2022-00089
• 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: 02/21/2022
• Supplement Dates FDA Received: 02/22/2022
• 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