SURG-O-VAC ASPIRATION TIP DENTAL

Description of Event or Problem

OUR FACILITY'S DENTAL CLINIC USES YOUNG DENTAL SURG-O-VAC ASPIRATION TIPS, WHICH WE HAVE BEEN STERILIZING AS THE PACKAGE LABEL SAYS AUTOCLAVABLE AND LETTER RECEIVED 12/03/2012 SAYS AUTOCLAVABLE UP TO 135C. ON (B)(6) 2020 I EMAILED THE COMPANY FOR MORE EXPLICIT STERILIZATION PARAMETERS (I.E, GRAVITY VERSUS PREVACUUM CYCLE AND EXPOSURE TIME). COMPANY REPLIED: "THE MEMO FORWARDED WITH THE CUSTOMER INJURY IS SEVERAL YEARS OLD AND OUT OF DATE. WE DO NOT HAVE A VALIDATED STERILIZATION PROTOCOL AND SO HAVE SINCE REMOVED ANY INFO FROM THE PRODUCT'S LABELING REGARDING STERILIZATION OR THE USE OF AN AUTOCLAVE IN A STERILIZATION PROCESS. THERE HAVE BEEN NO OTHER CHANGES TO THE MATERIAL OR MFG PROCESS AFTER OTHER THAN THE CHANGE TO THE LABELING /IFU." I EMAIL-REPLIED THAT DENTAL SUPPLY COMPANIES ARE STILL ADVERTISING SURG-O-VAC TIPS AS AUTOCLAVABLE. (B)(6). AFTER RECEIVING NO RESPONSE TO DATE ((B)(6) 2020) I CALLED THE COMPANY AND SPOKE TO THE SAME CUSTOMER SERVICE AGENT WHO EMAILED ME. SHE SAID IF SHE HADN'T EMAILED ME IT WAS BECAUSE YOUNG'S QUALITY AND REGULATORY DEPT HADN'T GOTTEN BACK TO HER. I ASKED IF I COULD SPEAK TO SOMEONE IN THE QUALITY AND REGULATORY DEPT AGENT SAID NO. I ASKED IF THEY HAD PHONES AND SHE SAID NO. PRODUCT IS STILL BEING ADVERTISED AS AUTOCLAVABLE AND PRODUCT PACKAGING STILL SAYS AUTOCLAVABLE, BUT COMPANY HAS NO VALIDATION FOR STERILIZATION. FDA SAFETY REPORT ID# (B)(4).