JAMSHIDI (TJ) SAFE-T PLUS BM TRAY 11GMAC

Description of Event or Problem

IT WAS REPORTED BY CUSTOMER THAT SEVERAL PHYSICIAN COMPLAINS OF DULL SCALPEL, POOR SAFETY CAP ON SCALPEL. PA WAS DOING A BONE MARROW BIOPSY ON A PATIENT AND WAS FINISHED USING THE SCALPEL- SAFETY CAP FAILED AND CUT PA WITH DIRTY SCALPEL. PA WAS SENT TO ED FOR BLOOD EXPOSURE AND EXPOSURE PACKET COMPLETED. THIS BONE MARROW TRAY ALSO DOES NOT HAVE A SHARPS PAD TO USE WHEN DONE WITH THE SHARPS. VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SEVERAL PHYSICIAN COMPLAINS OF DULL SCALPEL, POOR SAFETY CAP ON SCALPEL. PA WAS DOING A BONE MARROW BIOPSY ON A PATIENT AND WAS FINISHED USING THE SCALPEL- SAFETY CAP FAILED AND CUT PA WITH DIRTY SCALPEL. PA WAS SENT TO ED FOR BLOOD EXPOSURE AND EXPOSURE PACKET COMPLETED. THIS BONE MARROW TRAY ALSO DOES NOT HAVE A SHARPS PAD TO USE WHEN DONE WITH THE SHARPS.

Additional Manufacturer Narrative

PR 9209275 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0202. PATIENT PROBLEM CODE: F11. NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. SHOULD YOU EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT, EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. H3 OTHER TEXT : SEE MANUFACTURE NARRATION.