MAUDE Adverse Event Report: ST PAUL PORTEX PAIN MANAGEMENT KIT; ANESTHESIA CONDUCTION KIT

Lot Number 3666987

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation- the device was returned for evaluation.During examination and testing the device was found to function as expected with no leakage identified.The reported issue could not be confirmed.

Event Description

The device was in use with patient and the syringe was found to be leaking.No adverse effects reported.

Manufacturer Narrative

Other, other text: investigation received a smiths medical epifuse connector was tested with injection water through syringe with no leaking or abnormality noted.The complaint was not substantiated.Plan to monitor future complaints.

Event Description

Investigation received a smiths medical epifuse connector was tested with injection water through syringe with no leaking or abnormality noted.The complaint was not substantiated.Plan to monitor future complaints.

Manufacturer Narrative

Other, other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX PAIN MANAGEMENT KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 2-12-12 kitanagase-omotemachi,; minneapolis, MN 55442
• MDR Report Key: 11812800
• MDR Text Key: 250220196
• Report Number: 3012307300-2021-04242
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3666987
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Race: Asian