MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Catalog Number 100/382/116CZ

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Numbness (2415); Foreign Body In Patient (2687)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Report source: report source: (b)(6).

Event Description

Information was received that a smiths medical portex epidural catheter was inserted by hospital staff a patient's surgery.The reporter stated the device was placed at patient's l5 and ruptured while in use.It was reported the patient had pain with numbness in their legs and their surgery was delayed.Upon initial imaging of the catheter, the 5cm fragment could not be located and remained in the patient's body.The reporter then stated at a later date that "the catheter was located on a second resonance and is currently at l1".Subsequently, the patient was operated on two days after the event and discharged the following day.Additionally, the patient's pain and numbness was noted to have decreased.No additional adverse patient effects were reported.

• Brand Name: PORTEX EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC; olomouck 306,; hranice 1 - mesto; hranice, ; EZ
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9323943
• MDR Text Key: 166636262
• Report Number: 3012307300-2019-06435
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: 100/382/116CZ
• Device Lot Number: 3086868
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization