MAUDE Adverse Event Report: ARROW/ TELEFLEX INC TELEFLEX EPIDURAL KIT; ANESTHESIA CONDUCTION KIT

Model Number AK-05000

Device Problems Device Markings/Labelling Problem (2911); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2018

Event Type  Injury  

Event Description

The arrow epidural kit was used on a cse.Placement went easily although there are minimal depth markings on this catheter.Removed catheter at the end of the procedure with slight initial resistance but end that was removed looked like the metal tip of the original catheter.I was contacted by physician approx 2 months later when the patient was having a fluro-guided esi and a foreign body was seen between l2-3 space on fluoro and presumed to be retained epidural catheter.Patient asymptomatic- and recommended follow-up w/ neurosurgeon to see if the foreign body needs removal.

• Brand Name: TELEFLEX EPIDURAL KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW/ TELEFLEX INC
• MDR Report Key: 8306073
• MDR Text Key: 135678605
• Report Number: MW5083691
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AK-05000
• Device Catalogue Number: AK-05000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR