Needle stick. Upon completion of procedure, cleaning up back table, needle counter was closed. Needles slipped out when snapping counter together-hinge on needle counter not working causing needles to "pop" out. Lot numbers given are: 199779, 206385, and 210358.

H. 10 add'l mfr narrative: sections a, b, d, and f-info received from user facility. Mfr completed to the best of co's ability. B. 4, f. 8, and f. 11-mfr submitted report to fda on this date. F. 10-mfr determined appropriate codes. H. 3-eval summary: the user facility reported a needle stick to one staff member due to the hinge not working on a needle counter. The injury incident occurred on 04/16/2000 at the end of a bowel resection procedure, during clean up, and was reported to the mfr on 08/16/2000. The needle counter noted in the incident was discarded and not returned to the mfr for inspection. The mfr was provided three lot numbers that may have contained the incident device from an outside vendor. The original complaint stated two (2) nurses had received needle sticks. Add'l info from the user facility states only one needle stick occurred requiring blood to be drawn for testing per the user facility protocol. It is further stated the staff member has continued to work with no off days due to the 4/16/2000 incident. The user facility perioperative clinical coordinator, stated they had received several complaints regarding closure of the needle counter, but no documentation was provided to the mfr for follow-up of those complaints. The mfr has notified the outside vendor about this complaint. The outside vendor is in the process of evaluating controlled/non-released inventory from the lot number provided. Results: add'l info regarding inspection and eval of the controlled/non-released inventory from the lot numbers provided is in process by the outside vendor. Conclusion: the mfr has requested add'l info from the outside vendor to determine the exact cause of the incident. A supplemental report will be filed upon eval of any add'l info received. The info contained herein is being submitted to the fda to comply with regulations relating to medical device reporting. This submission is not intended to and shall not constitute an admission on behalf of deroyal industries, inc. , that the product was in any way causally related to an injury.