Description of Event or Problem · 0
PT UNDERWENT PROSTATE BIOPSY AT [REDACTED] UROLOGY. ONGOING ISSUES WITH BARD MAX-CORE BIOPSY DEVICES. ALTERNATIVE BARD DEVICE IDENTIFIED BY CORPORATE SUPPLY CHAIN ON FORMULARY - BARD MARQUEE DEVICE. BARD REP TO CLINIC AND PROVIDED IN-SERVICE TO PROVIDERS ON DEVICE. BARD MARQUEE WAS USED FOR BIOPSY. PT EXPERIENCED SIGNIFICANT RECTAL BLEEDING DURING BIOPSY. UNABLE TO COMPLETE BIOPSY. BLEEDING CONTINUED POST PROCEDURE. PT ASSISTED BACK TO CLINIC AND DR. [REDACTED] AWARE. PT BROUGHT TO ER FOR FURTHER EVAL AND WAS ADMITTED TO HOSPITAL FOR OBSERVATION. MARQUEE DEVICE WAS USED FOR A SECOND BIOPSY THAT ALSO RESULTS IN INCREASED RECTAL BLEEDING POST PROCEDURE, BUT PT WAS DISCHARGED FROM CLINIC WITHOUT COMPLICATIONS. BARD MARQUEE MQK1825. LOT NUMBER 0001641391. [DATE REDACTED] REGULATORY SPECIALIST [REDACTED] REACHED OUT TO INFORM SUPPLY CHAIN THAT THIS EVENT IS BEING REPORTED TO THE DPH [DEPARTMENT OF PUBLIC HEALTH]. SUPPLY CHAIN ASKED IF THE DEVICE WAS AVAILABLE STILL, IN WHICH CASE IT SHOULD BE RETAINED IN RISK MANAGEMENT AND NOT RELEASED TO THE VENDOR. [DATE REDACTED] AND IF THE DEVICE WAS STILL AVAILABLE (IF YES, SHOULD BE SENT TO LEGAL/RISK - NOT TO VENDOR). PER [REDACTED] MEETS [REDACTED] DPH REPORTING CRITERIA "[REDACTED] DPH CRITERIA UNDER NQF 2B. PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THE USE OR FUNCTION OF A DEVICE IN PATIENT CARE, IN WHICH THE DEVICE IS USED OR FUNCTIONS OTHER THAN AS INTENDED." [DATE REDACTED] CLINICAL SITE REACHED OUT TO REP TO SEE IF THEY WOULD HAVE ANY INSIGHT AS TO WHY THE BLEEDING OCCURRED. AWAITING RESPONSE. MANUFACTURER RESPONSE FOR BIOPSY DEVICE, MARQUEE (PER SITE REPORTER).