BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION WAS PERFORMED DUE TO PROBLEM WITH GENERATE CO2 ENVIRONMENT WITH GASPAK EZ CO2 POUCH CATALOG 260684, BATCH NO.: 5303157 ON RETENTION SAMPLES AND RETURNED GOODS. THE INVESTIGATION REQUIRED TO PERFORM FUNCTIONAL TEST (MICROBIOLOGICAL PERFORMANCE, GAS CONCENTRATION TEST), VISUAL INSPECTION, INCOMING AND BATCH RECORD REVIEW. FUNCTIONAL TEST ON RETENTION SAMPLES AND RETURNED GOODS SHOWED SATISFACTORY RESULTS ON MICROBIOLOGICAL PERFORMANCE AND UNSATISFACTORY RESULTS ON GAS CONCENTRATION TEST. LOW CO2 LEVEL OBSERVED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. INCOMING RECORD NOT AVAILABLE, LOT RECEIVED UNDER SKIP LOT PROGRAM. A COMPLAINT HISTORY REVIEW WAS CONDUCTED. NO TREND WAS FOUND RELATING TO THE INCIDENT LOT NUMBER. HOWEVER, A TREND WAS IDENTIFIED DUE TO CUSTOMER CLAIM. COMPLAINT IS CONFIRMED. THE SUPPLIER HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THIS SITUATION THROUGH CORRECTIVE AND PREVENTIVE ACTIONS PROCESS. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM, THE CUSTOMER NOTICED THE SACHETS ARE INTERMITTENTLY FAILING TO GENERATE THE APPROPRIATE CO2 ENVIRONMENT ON UNSPECIFIED NUMBER OF PATIENT SAMPLES. HOWEVER, WHEN THE CUSTOMER TESTED A DIFFERENT LOT FROM A SISTER HOSPITAL, THE SACHETS WORKED AS EXPECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.