MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CATHETER 18G LATERAL EYES CLEAR+; ANESTHESIA CONDUCTION KIT PRODUCT CODE: CAZ

Catalog Number 100/382/118CZ 

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received that during the removal of a smiths medical portex epidural catheter 18g lateral eyes clear, it ruptured in the patient.Ct, x-ray and mri were performed and in none of the exams did the catheter appeared.No adverse patient effects were reported.

• Brand Name: PORTEX EPIDURAL CATHETER 18G LATERAL EYES CLEAR+
• Type of Device: ANESTHESIA CONDUCTION KIT PRODUCT CODE: CAZ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomoucka 306,; hranice 1 - mesto; hranice, 75301 ; EZ 75301
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8838782
• MDR Text Key: 152566814
• Report Number: 3012307300-2019-03595
• 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: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2022
• Device Catalogue Number: 100/382/118CZ
• Device Lot Number: 3456322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1