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

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device water was injected into the filter with a syringe, liquid leakage was confirmed from the central part of one side of the flat filter.The customer reported condition was confirmed.Problem source was traced to supplier.

Event Description

It was reported that medical fluid was leaking from the product during a one-shot infusion on a smiths medical, device.The customer then noticed the epidural filter was broken and the leakage occurred in it.No adverse patient effects were reported.The reported part number is nce6145.

• Brand Name: PORTEX EPIDURAL
• Type of Device: ANESTHESIA CONDUCTION KIT PRODUCT CODE: CAZ
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10027367
• MDR Text Key: 189977030
• Report Number: 3012307300-2020-03789
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 05/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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