MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX SMITHS MEDICALS EPIDURAL CATHETER; EPIDURAL CATHETER/NEEDLE CONDUCTION

Model Number REF #NEPI-15600-20

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/28/2018

Event Type  Injury  

Event Description

Epidural catheter fragment (approx 5cm) retained in pt.

• Brand Name: PORTEX SMITHS MEDICALS EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER/NEEDLE CONDUCTION
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.
• MDR Report Key: 7964964
• MDR Text Key: 123865844
• Report Number: MW5080544
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: REF #NEPI-15600-20
• Device Lot Number: 3655687
• 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: 27 YR