MAUDE Adverse Event Report: ST PAUL PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 001203

Device Problem Packaging Problem (3007)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.Operator of device is unknown.Manufacturer site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.A product sample was received for evaluation.Visual and functional testing were performed.The reported event was confirmed.The root cause of the reported issue was found to be some products were not firmly pressed when the label was attached.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that prior to opening, the product label was stuck to another package.No patient injury was reported.

• Brand Name: PORTEX OXYGEN/AEROSOL ADAPTERS AND CONNECTORS
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 15492354
• MDR Text Key: 306162494
• Report Number: 3012307300-2022-20384
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 001203
• Device Lot Number: 1909021A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2022
• 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