POSIFLUSH

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. G.4. ADDITIONAL 510K: K141311; K250884.

Description of Event or Problem

IT WAS REPORTED, SYRINGE 10 ML SALINE, MOLD ON THE CAP.. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE A DEFECTIVE SALINE FLUSH LOT NUMBER 6085955. THE REF#306546, PLEASE CHECK YOUR INV AND REMOVE. WHO IS THE MANUFACTURE REP FOR THIS ITEM? ADDITIONAL INFORMATION: THE PRODUCT HAS MOLD ON THE LUER LOCK CAP AND THE LABELING IS INSIDE OUT.