MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00820

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Potential lot number: 71f18j0205, 71f18k1608.

Event Description

It was reported that "no measurement curve was visible with the artery catheters.".

Event Description

It was reported that "no measurement curve was visible with the artery catheters.".

Manufacturer Narrative

(b)(4).The customer returned one arterial catheter for evaluation.The catheter contained signs of use in the form of biological material.Visual examination of the catheter revealed one slight kink.The catheter body contained one slight kink 79 mm from the distal tip.The total length of the catheter body measured to be 84 mm which is within specification per product drawing.The returned catheter was flushed using a lab inventory syringe.No blockages or leaks were observed.A lab inventory guide wire was able to advance through the returned guide wire with minimal resistance.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit warns the user, "care should be exercised that the indwelling catheter is not inadvertently kinked at hub area when securing catheter to patient.Kinking may weaken wall of catheter and cause a fraying or fatigue of the material, leading to possible separation of catheter.Precaution: do not suture directly to outside diameter of catheter body to minimize the risk of damaging the catheter or adversely affecting monitoring capabilities".The customer report of no measurement curve could not be confirmed by complaint investigation of the returned sample.However, the catheter body contained one slight kink that can attribute to seeing defects in the measurement curve.The returned catheter passed all functional, and dimensional testing.A device history record review was performed based on sales history with no relevant findings.Based on the sample provided, it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8353827
• MDR Text Key: 136630612
• Report Number: 3006425876-2019-00116
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SAC-00820
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1