PORTEX CUFF PRESSURE MONITORING

Additional Manufacturer Narrative

D3. MANUFACTURING PLANT ADDRESS, CITY, ZIP CODE, STATE, COUNTRY: CORRECTED. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: ONE SAMPLE OF 100/568/000 CUFF INFLATOR/PRESSURE GAUGE EA WITHOUT ORIGINAL PACKAGE WAS RECEIVED FOR INVESTIGATION. UNDER VISUAL INSPECTION WE NOTICED THAT CONNECTION PORT IS BROKEN AS REPORTED BY CUSTOMERS. CUFF INFLATOR ITSELF IS PACKED INTO BUBBLE FOIL AND THEN IT IS INSERTED TO CARTON TO AVOID ANY SIMILAR DAMAGE. DUE TO FACT THAT RETURNED SAMPLE WAS 100% REINSPECTED AND RELABELED IN MKOM PRIOR DISTRIBUTION TO MARKET IT IS THE MOST PROBABLE THAT SUCH DAMAGE HAPPENED DURING OR AFTER RELABELING ACTIVITIES OR DURING TRANSPORT. TRUE ROOT CAUSE OF THIS ISSUE REMAINS UNKNOWN. THIS IS AN ISOLATED INCIDENT. NO SIGNAL OF SIMILAR CUSTOMER COMPLAINTS WAS IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER OPENING THE PACKAGE, THE LURE CONNECTION PORT BROKE ON THE FIRST USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

B3: DATE OF EVENT IS UNKNOWN. 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 INFORMATION BECOMES AVAILABLE.