MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-22702-E

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the luer hub of the extension line does not fit well with the syringe.The md changed to new kit and finished the procedure without abnormality.

Manufacturer Narrative

(b)(4).The customer returned multiple components from a cvc set.The catheter and the arrow raulerson syringe (ars) will be reviewed as part of this complaint investigation.Signs-of-use in the form of biological material was observed on the inner cannula of the ars.Visual analysis did not reveal any defects or anomalies.The inner diameter of the proximal opening on the distal luer hub measured.169", which is within the specification limits of.1680"-.1697" per the distal extension line graphic.The inner diameter of the proximal opening on the proximal luer hub measured.169", which is within the specification limits of.1680"-.1697" per the proximal extension line graphic.With the distal end of the catheter body occluded, the returned ars was filled with water and used to pressurize both the proximal and distal extension lines.No defects or anomalies were observed.The ars syringe appeared to be secure within both the proximal and distal luer hubs.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 the kit informs the user, "to lessen the risk of disconnects, only securely tightened luer-lock connections should be used with the device".The report that the connection between the catheter luer hubs and the ars was not secure could not be confirmed through complaint investigation.Visual analysis did not reveal any defects or anomalies.The catheter luer hubs met all relevant dimensional requirements.Additionally, functional and additional testing revealed that the connection between the ars and the luer hubs is functioning as intended.A device history record review was performed based on sales history, and no relevant findings were identified.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: the luer hub of the extension line does not fit well with the syringe.The md changed to new kit and finished the procedure without abnormality.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10001300
• MDR Text Key: 189038183
• Report Number: 3006425876-2020-00357
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-22702-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1