MAUDE Adverse Event Report: ST PAUL PORTEX DISPOSABLE MANOMETER; MONITOR, AIRWAY PRESSURE

Model Number	008201
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple photographs of the manometer were provided in support of the investigation.It was confirmed that there were ink stains present on the outside of the manometer.Which are not in accordance with manufacturer specifications.The root cause of the reported event was determined to be related to the mishandling of the device during the manufacturing process, resulting in ink stains on the outside of the manometer.To address the issue, a notification was provided to all manufacturing operators to notify regarding this issue, and a (b)(6) implementation in the machine fixture to prevent the issue from occurring.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that there are ink stains on the surface of the nanometer.There was no patient involvement reported.

• Brand Name: PORTEX DISPOSABLE MANOMETER
• Common Device Name: MONITOR, AIRWAY PRESSURE
• 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; minneapolis, MN 55442
• MDR Report Key: 13537500
• Report Number: 3012307300-2022-03434
• Device Sequence Number: 14469060
• Product Code: CAP
• UDI-Device Identifier: 10351688426352
• UDI-Public: 10351688426352
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/04/2024
• Device Model Number: 008201
• Device Catalogue Number: 008201
• Device Lot Number: 4089533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown