MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 5CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00520

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that after 24 hours there was a blockage of the arterial catheter.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that after 24 hours there was a blockage of the arterial catheter.

Event Description

It was reported that after 24 hours there was a blockage of the arterial catheter.

Manufacturer Narrative

(b)(4).The customer returned one arterial catheter for evaluation.Visual examination did not reveal any defects or anomalies.No kinks or blockages were detected in the catheter.The total length of the catheter body measured to be 55 mm which is within specifications of 52-56 mm per product drawing.The outer diameter of the catheter measured to be 1.09 mm which is within specifications of 1.04-1.09 mm per product drawing.The returned catheter was flushed using a lab inventory water-filled syringe.No blockages or leaks were detected.A lab inventory guide wire was able to pass through the returned catheter with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "care should be exercised that 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 material, leading to possible separation of the catheter." the customer report of a blocked catheter could not be confirmed by complaint investigation of the returned sample.The catheter passed all relevant dimensional and functional 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.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 5CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9580737
• MDR Text Key: 180129299
• Report Number: 3006425876-2020-00032
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2019

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: 08/03/2024
• Device Catalogue Number: SAC-00520
• Device Lot Number: 71F19H2378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/30/2020; 02/04/2020
• Supplement Dates FDA Received: 01/30/2020; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1