MAUDE Adverse Event Report: ST PAUL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number P1236B 15

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.Observation of the connector revealed burrs inside the sleeve, indicating damage.The catheter did not show any abnormalities, such as stretching or damage.Next, the returned catheter was connected to the returned connector and a catheter removal test was performed in accordance with the product standards of the manufacturing site.The same test was performed by connecting a stock catheter to the returned connector, but the catheter was not held for the specified time and did not comply with the standard.To recreate the situation where the catheter was pulled out of the infuser pump, the catheter was disconnected from the connector with excessive force after connecting the connector to the stock catheter.After observing the inside of the sleeve of the connector, it was found that burrs were generated as in the returned connector.Therefore, it is highly probable that burrs or damage inside the connector occurred when the infuser pump dropped.However, we could not determine whether the connector complies with the standard.The root cause of the issue could not be determined.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that when an infuser pump fell off by accident during the use of it, the catheter slipped off from the connector.No patient injury was reported.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; sapporo-city, hokkaido; minneapolis, MN 55442
• MDR Report Key: 15324435
• MDR Text Key: 305256511
• Report Number: 3012307300-2022-16876
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care 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: Health Professional
• Device Catalogue Number: P1236B 15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1