MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-15703-KR

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: the user felt a strong resistance when inserting the catheter in the patient and managed to "forcibly" insert it.No patient harm reported.

Manufacturer Narrative

Qn#: (b)(4).The customer returned one 3-l cvc catheter for evaluation.Signs of use in the form of biological material were present on the catheter body.A slight bend was noted in the distal end of the catheter but no other defects or anomalies were present.The catheter body measured 220 mm which is within specifications of 207-227 mm per catheter product drawing.The outer diameter of the catheter body measured 2.443 mm which is within specifications of 2.39-2.49 mm per catheter extrusion graphic.A lab inventory 0.826 mm dia guide wire was passed through the returned catheter per ifu which states, "thread tip of catheter over swg.Sufficient swg length must remain exposed at hub end of catheter to maintain a firm grip on swg." the guide wire was able to pass through the catheter from both the proximal and distal end with minimal resistance.All three lumens were flushed using a lab inventory syringe per ifu which states , "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)." no leaks or blockages were detected.A device history record review was performed with no relevant findings.The customer report of a catheter difficult to insert could not be confirmed by complaint investigation of the returned sample.The catheter passed all relevant visual, functional, and dimensional testing, and a device history record review was performed with no relevant findings.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The complaint is reported as: the user felt a strong resistance when inserting the catheter in the patient and managed to "forcibly" insert it.No patient harm reported.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11914323
• MDR Text Key: 253562473
• Report Number: 3006425876-2021-00486
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

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: No Information
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: ASK-15703-KR
• Device Lot Number: 71F20H0803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1