TAT LIMB HOLDER; 2798

Description of Event or Problem

CUSTOMER IS REPORTING A COMPLAINT ON THE PRODUCTS 2799 AND 2798 LOT# 3081T146 4254T193 & 4240T421. CUSTOMER STATES THAT THREE DIFFERENT RESTRAINTS MALFUNCTIONED AND WOULD NOT LOCK AS THEY WERE INTENDED TO. THEY HAD TO USE A HARD RESTRAINT AS A RESULT. INJURY WAS INVOLVED IN THE PATIENT INCIDENT BUT NO DETAILS ON NATURE OF THE INJURY. CUSTOMER NOTES THE ONLY WAY THEY COULD GET THE RESTRAINT TO LOCK WAS WITH A MULTI-TOOL FROM SECURITY.

Additional Manufacturer Narrative

PRODUCT IS SCHEDULED TO BE RETURNED BUT HAS NOT BEEN RECEIVED IN BY MANUFACTURER AT THE TIME OF THIS REPORT. THEREFORE, THIS REPORT IS BASED SOLELY ON THE INFORMATION PROVIDED BY THE CUSTOMER. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES TO BEFORE EACH USE, CHECK CUFFS AND STRAPS FOR CRACKS, TEARS, AND/OR EXCESSIVE WEAR OR STRETCH, BROKEN BUCKLES OR LOCKS, AND/OR THAT HOOK-AND-LOOP ADHERES SECURELY AS THESE MAY ALLOW PATIENT TO REMOVE CUFF . DISCARD IF DEVICE IS DAMAGED OR IF UNABLE TO LOCK. THE IFU ALSO PROVIDED EXTRA WARNING TO NOT USE THIS DEVICE WITH SOMEONE WHO HAS CONTINUED HIGHLY AGGRESSIVE OR COMBATIVE BEHAVIOR, SELF-DESTRUCTIVE BEHAVIOR, OR DEEMED TO BE AN IMMEDIATE RISK TO OTHERS OR TO SELF. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).

Description of Event or Problem

SUPPLEMENTAL MEDWATCH BEING SENT FOR ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

PRODUCT WAS NOT RETURNED BUT WAS RETURNED FROM USER FOR OTHER FILES REF (B)(4). VISUAL FINDINGS NOTED VELCRO HAS FIBERS STUCK TO IT AND IS WORN. STRAPS ARE IN GOOD CONDITION WITH SOME MINOR WEAR. EVALUATION TESTED WRIST AND BED STRAP BY INSERTING THEM INTO THE BUCKLES AT MULTIPLE LOCATIONS ALONG THE STRAPS. RESISTANCE WAS NOTED, AND THE BUCKLES WERE DIFFICULT TO CLOSE AND LOCK WITHOUT APPLYING ADDITIONAL FORCE; HOWEVER, ALL BUCKLES ULTIMATELY LOCKED. THESE CONDITIONS WOULD BE IDENTIFIED DURING PRE-USE CHECK PREVENTING THE DEVICE FROM BEING PUT INTO USE. ADDITIONAL COMMUNICATION WITH THE CUSTOMER NOTED THERE WERE NO INJURIES REPORTED AND RESTRAINTS ARE LAUNDERED BY A 3RD PARTY. BEING THAT THE DEVICE HAS BEEN IN USE FOR OVER 1 YEAR, IT IS LIKELY NORMAL WEAR AND TEAR OR IMPROPER LAUNDERING THAT CONTRIBUTED TO THE REPORTED ISSUE. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES TO BEFORE EACH USE, CHECK CUFFS AND STRAPS FOR CRACKS, TEARS, AND/OR EXCESSIVE WEAR OR STRETCH, BROKEN BUCKLES OR LOCKS, AND/OR THAT HOOK-AND-LOOP ADHERES SECURELY AS THESE MAY ALLOW PATIENT TO REMOVE CUFF . DISCARD IF DEVICE IS DAMAGED OR IF UNABLE TO LOCK. THE IFU ALSO PROVIDED EXTRA WARNING TO NOT USE THIS DEVICE WITH SOMEONE WHO HAS CONTINUED HIGHLY AGGRESSIVE OR COMBATIVE BEHAVIOR, SELF-DESTRUCTIVE BEHAVIOR, OR DEEMED TO BE AN IMMEDIATE RISK TO OTHERS OR TO SELF. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE (B)(4).