MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL MINIPACK SYSTEM; CATHETER, CONDUCTION, ANESTHETIC

Model Number 100/391/118

Device Problem Disconnection (1171)

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

Event Date 07/15/2023

Event Type  Injury  

Manufacturer Narrative

Other, other text: d4: udi section is unknown, no information available.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device was correctly positioned without any procedural issues.Upon rechecking after about an hour, the connection between the catheter and filter was found to be disconnected.It was not possible to reconnect it, and consequently, it was removed.There was no injury or adverse effects to the patient.The situation was resolved by that the doctor performing a spinal anesthesia, as there was not enough time to insert another catheter.

Manufacturer Narrative

One used device was received for investigation without its original packaging.Visual inspection noted the rotating collar (luer lock) was detached from the returned filter.The root cause was damage due to overtightening the connection by the user.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken and there was no trend of confirmed customer complaints was identified.

• Brand Name: PORTEX EPIDURAL MINIPACK SYSTEM
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17559985
• MDR Text Key: 321285660
• Report Number: 3012307300-2023-08169
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100/391/118
• Device Catalogue Number: 100/391/118CZ
• Device Lot Number: 4301474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR