PORTEX DISPOSABLE HYPERINFLATION PRESSURE MONOMETER

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. E1 INITIAL REPORTER PHONE NUMBER: (B)(6). E2 - INCORRECT DUE TO SYSTEM LIMITATIONS. INITIAL REPORTER IS FROM PROCUREMENT AND LOGISTICS DEPARTMENT. H3 - OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. 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.

Description of Event or Problem

IT WAS REPORTED THAT 3 PIECES HAD "DIRT AND IMPURITIES". NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

D9: DATE RETURNED TO MFG.: 3/25/2024. EIGHT (8) UNITS WERE RECEIVED WITH THEIR ORIGINAL PACKAGING. RECEIVED SAMPLES 2 AND 5 ARE FOR A SEPARATE COMPLAINT INVESTIGATION ((B)(4)) AND ARE NOT INCLUDED WITH THIS DEVICE ANALYSIS. PER VISUAL INSPECTION, BURRS WERE FOUND BETWEEN THE PISTON AND SPRING IN SAMPLES ONE, THREE AND SIX, SAMPLE FOUR SHOWS A HAIR IN THE SPRING NOZZLE. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE OF THE CONTAMINATION IS CAUSED BY INADEQUATE FOLLOWING OF THE PROCEDURES DURING MANUFACTURING ASSEMBLY. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. AWARENESS WAS MADE TO OPERATION PERSONNEL TO EXPLAIN THE IMPORTANCE OF ADHERING TO, AND FOLLOWING PROCEDURE AND THE ISSUE WILL BE MONITORED FOR THRESHOLD OR ESCALATION.