BD BBL¿ DRYSLIDE¿ PYR KIT

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING A BD BBL¿ DRYSLIDE¿ PYR KIT A TECHNICIAN RECEIVED A CUT FROM A GLASS AMPOULE THAT WENT THROUGH THE PACKAGING. THE PATIENT RECEIVED MEDICAL EVALUATION FOLLOWING THE INCIDENT AND WAS MONITORED FOR FEVER AND INFECTION.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING A BD BBL¿ DRYSLIDE¿ PYR KIT A TECHNICIAN RECEIVED A CUT FROM A GLASS AMPOULE THAT WENT THROUGH THE PACKAGING. THE PATIENT RECEIVED MEDICAL EVALUATION FOLLOWING THE INCIDENT AND WAS MONITORED FOR FEVER AND INFECTION.

Additional Manufacturer Narrative

CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: QUALITY INITIATED AN INVESTIGATION ON DRY SLIDE PYR PRODUCT. THE INVESTIGATION REQUIRED TO PERFORM FUNCTIONAL TEST (FOR AMPULE BREAKAGE-DIFFICULT TO OPEN), VISUAL INSPECTION TO RETENTION SAMPLES, INCOMING AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING VISUAL INSPECTION. SATISFACTORY FUNCTIONAL TEST. RETENTION SAMPLES (AMPULE) WERE EASILY OPENED AND GLASS WERE NOT BROKEN DURING THE PROCESS. INCOMING AND BATCH RECORD REVIEW DID NOT SHOWED ANY EVIDENCE OF CUSTOMER CLAIM. AN INVESTIGATION WAS REQUESTED TO AMPULE SUPPLIER. THEY EVALUATED THE PRODUCT BHR, CUSTOMER COMPLAINTS FILES AND RETENTION SAMPLES. NO EVIDENCE OF BROKEN AMPULE (DURING THE OPENING PROCESS) WERE REPORTED. NO TREND OR ADDITIONAL COMPLAINT DUE TO SAME CLAIM WAS RECEIVED IN THEIR FACILITY. COMPLAINT WILL BE MONITORED FOR TREND. PRODUCT HAZARD ANALYSIS WAS EVALUATED. IT WAS OBSERVED THAT CUSTOMER CLAIM WAS NOT REFERENCED IN THE HAZARD REPORT. INVESTIGATION CONCLUSION: THE MOST PROBABLE ROOT CAUSE IDENTIFIED WAS INCORRECT HANDLING BY USER. NO EVIDENCE OF DEFECTIVE PRODUCTS WERE FOUND DURING AMPULE SUPPLIER AND BD (B)(4) INVESTIGATIONS. IN ADDITION, NO TREND HAS BEEN IDENTIFIED FOR DIFFICULT TO OPEN/BROKEN AMPULE DEFECT.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING A BD BBL¿ DRYSLIDE¿ PYR KIT A TECHNICIAN RECEIVED A CUT FROM A GLASS AMPOULE THAT WENT THROUGH THE PACKAGING. THE PATIENT RECEIVED MEDICAL EVALUATION FOLLOWING THE INCIDENT AND WAS MONITORED FOR FEVER AND INFECTION.