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

Catalog Number 932/018/0265

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

It was reported the device was placed in use with patient on (b)(6) 2021 for pain control of paralytic ilius.The reporter stated the patient was receiving some pain relief but during night the patient had "violent pain".The staff checked the device and found the system had separated at the epidural filter.No adverse effects reported.

• Brand Name: PORTEX EPIDURAL CUSTOM KIT
• Type of Device: ANESTHESIA CONDUCTIVE KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11615552
• MDR Text Key: 243854433
• Report Number: 3012307300-2021-02843
• 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,user facility
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 932/018/0265
• Device Lot Number: 3801324
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 56 YR