MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) FLEX TIP EPIDURAL CATHERIZATION KIT; EPIDURAL CATHETER

Model Number IPN045607

Device Problem Connection Problem (2900)

Patient Problem Pain (1994)

Event Date 04/09/2020

Event Type  malfunction  

Event Description

Epidural line incorrectly connected to iv tubing of the central line.Roughly 3hrs following the incorrect connection they noticed increasing pain.Epidural line and pump checked.Epidural line connected to epidural port.After event discovered, the pt.Was assessed and ekg monitoring initiated.The pcea line was connected to the pt's.Central line not the epidural line/ catheter located in the pt.Spine.Iv pain medication given iv and no other adverse event occurred.This involved 2 clinicians (rn) in the event.

• Brand Name: FLEX TIP EPIDURAL CATHERIZATION KIT
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9980936
• MDR Text Key: 188354922
• Report Number: 9980936
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/16/2020

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 Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19M0338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA