MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET ANESTHESIA CONDUCTION KIT

Model Number IPN046311

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4). The device investigation is pending. Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the plunger of the syringe is dysfunctional. It has a lack of resistance. Clinical consequences: another syringe was used, and the medical staff was made aware of this issue that can happen.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 9437701
• MDR Text Key: 179425358
• Report Number: 3006425876-2019-00985
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/12/2021
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19H2034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage