MAUDE Adverse Event Report: SMITHS MEDICAL SMITHS MEDICAL; EPIDURAL TRAY

Model Number A3947-17

Device Problems Fracture (1260); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Code Available (3191)

Event Date 12/30/2017

Event Type  malfunction  

Event Description

Smiths medical epidural tray: ref a3947-17, lot 3360737, expire 11/01/2018.Epidural was placed with ease, 10 cm at skin.With test dose noted skin elevation and expansion of subq., tissue.Attempt at pulling back cath was met with some resistance.Further pulling caused break of casing and unspooling of the epidural cath (fractured catheter).Failed attempt at cath removal.Required surgery under general anesthesia to remove the retained piece of epidural catheter.Pt made full recovery without any deficits.

• Brand Name: SMITHS MEDICAL
• Type of Device: EPIDURAL TRAY
• Manufacturer (Section D): SMITHS MEDICAL; st paul MN 55112
• MDR Report Key: 7240963
• MDR Text Key: 99130601
• Report Number: MW5075053
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: A3947-17
• Device Lot Number: 3360737
• Was Device Available for Evaluation?: Yes
• 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: 31 YR
• Patient Weight: 73