MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-15703

Device Problem Obstruction of Flow (2423)

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

Event Date 03/18/2023

Event Type  malfunction  

Event Description

It was reported "arrow 7fr 3-way catheter with obstructed midline is removed from the patient and you must use a lot of force to be able to release it." a new catheter was placed.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The report of a blocked catheter was not able to be confirmed as part of this complaint investigation.The customer returned one, opened cvc kit containing a 3-lumen catheter.Signs-of-use in the form of biological material were observed.Visual analysis did not reveal any obvious defect or anomalies.The catheter body length from the juncture hub to the distal tip measured 218mm via calibrated ruler, which is within the specification limits of 207mm-227mm per the catheter product drawing.The catheter body outer diameter measured 0.09665" via calibrated micrometer, which is within the specification limits of 0.094"-0.098" per the catheter extrusion product drawing.Functional inspection was performed per ifu statement, "flush lumen(s) to completely clear blood from catheter", where a lab inventory syringe filled with water was attached to all three extension lines and flushed.No blockages were encountered as the water was able to exit through the respective skive holes.Additionally, a lab inventory 0.032" guide wire was also inserted through the catheter body per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".Little to no resistance was encountered as the guide wire passed completely through the assembly.The catheter product drawing and the catheter extrusion product drawing were reviewed as part of this complaint investigation.The ifu provided with the kit informs the user, "open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure".The ifu also states, "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".A device history record review was performed, and no relevant findings were identified.The report of a blocked catheter was not able to be confirmed as part of this complaint investigation.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "arrow 7fr 3-way catheter with obstructed midline is removed from the patient and you must use a lot of force to be able to release it." a new catheter was placed.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16933648
• MDR Text Key: 315236287
• Report Number: 9680794-2023-00350
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 04/20/2023

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 Catalogue Number: CV-15703
• Device Lot Number: 14F22B0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 13 YR