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

Model Number IPN046311

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the catheter was inserted was success.But when they removed the trocar(which is the improper term used - can be the needle tbc) the catheter separated in 2 at 2/3rd of the upper point.Clinical consequences: no consequence because the catheter was still long enough to be used.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without a sample.

Event Description

It was reported that the catheter was inserted was success.But when they removed the trocar(which is the improper term used - can be the needle tbc)the catheter separated in 2 at 2/3rd of the upper point.Clinical consequences: no consequence because the catheter was still long enough to be used.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9552751
• MDR Text Key: 179718429
• Report Number: 3006425876-2020-00048
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19G2970
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1