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

Lot Number 191226 OR 200211

Device Problem Disconnection (1171)

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

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

The sample was returned from the customer for evaluation.When observing the male connector of the filter, it was confirmed that the retention edge which is designed to hold rotating collar connected with filter was damaged.As a result of the investigation, it was confirmed that the retortion edge was damaged and flattened, and it is possible that this event was caused.The timing of the collapse of the retortion edge and the cause of the reported event could not be identified.The occurrence of this event will be notified to our manufacturing department and this event will be recorded in the database to monitor the future occurrence.Device history record review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.(b)(4).

Event Description

It was reported that when the epifuse connector was connected with the filter, the connection part broke.No patient injury reported.

• Brand Name: PORTEX EPIDURAL CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15322063
• MDR Text Key: 305377084
• Report Number: 3012307300-2022-16812
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K781052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 191226 OR 200211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1