PORTEX MANUAL RESUSCITATOR

Additional Manufacturer Narrative

D9: DATE RETURNED TO MFG.: 11/9/2024. H3 AND H6. EVALUATION CODES: UPDATED. TWELVE SAMPLES WERE RECEIVED WITHOUT THE ORIGINAL PACKAGE. PER VISUAL INSPECTION, IT WAS POSSIBLE TO DETECT DAMAGE IN THE TWELVE BREATHING BAGS. THE COMPLAINT WAS CONFIRMED. BASED ON THE ANALYSIS CONDUCTED IN THE SAMPLES PROVIDED, THE BREATHING BAGS PRESENT DAMAGE, ROOT CAUSE CANNOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS SINCE THE FAILURE REPORTED COULD NOT BE REPRODUCED USING THE TOOLS FROM ASSEMBLY PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE COMPLAINT FAULT HAS BEEN ESCALATED TO ADDRESS A FULL ROOT CAUSE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PRE-USE CHECK, THERE WERE MULTIPLE BROKEN OR NEARLY BROKEN ITEMS IN THE ANESTHETIC BAG. DISCONTINUED USE AND USED ANOTHER ONE. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

Additional Manufacturer Narrative

B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. D4: LOT NUMBER, EXPIRATION DATE, AND H4: DEVICE MANUFACTURE DATE ARE UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. G5: NO 510K THIS CATALOG NUMBER IS NOT SOLD IN US. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. 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.

Additional Manufacturer Narrative

D4: INSUFFICIENT INFORMATION WAS PROVIDED TO BE ABLE TO DETERMINE THE FULL UDI. **UDI RELATED DATA QUALITY UPDATES ONLY**.