MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 18 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00818

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.

Event Description

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

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer returned four representative samples for analysis.Visual analysis of the representative samples did not reveal any defects or anomalies.In order to perform dimensional analysis on the returned catheters, each of the representative samples were opened.The catheters were measured and all met dimensional specifications.A lab inventory syringe was used to inject water through the representative catheters.No issues were identified.The reported issue of an occlusion could not be confirmed without the actual complaint sample returned.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "indwelling catheter should be routinely inspected for desired flow rate, security of dressing, and possible migration.Do not use scissors to remove dressing to minimize the risk of cutting catheter".The ifu also states, "it is recommended to check patency of catheter at least every three hours by delivering a bolus of isotonic saline.It is recommended to use heparinized isotonic saline".The report of a blocked arterial catheter could not be confirmed through complaint investigation as the customer did not return the actual complaint sample, only representative samples.Visual analysis did not reveal any relevant defects or anomalies on any of the returned representative samples.The catheters also met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.The root cause cannot be determined as the actual complaint sample was not returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

Qn#(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.

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9580466
• MDR Text Key: 180128960
• Report Number: 3006425876-2020-00025
• 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

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SAC-00818
• Device Lot Number: 71F19J1968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1