CERVICAL COLLAR, EMT SELECT, ONE PIECE, ADULT UNIV
Received Mar 18, 2024 · Event occurred Jan 31, 2024
Report 3004605321-2024-00001 · MDR key 18921816
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NURSE WENT TO APPLY THE C-COLLAR TO A PATIENT AND THE FRONT NECK PIECE SPLIT.
Additional Manufacturer Narrative
A VOLUNTARY MEDWATCH REPORT (#MW5151053) WAS RECEIVED ON 02/20/2024 REPORTING A NURSE WENT TO APPLY THE C-COLLAR TO A PATIENT AND THE FRONT NECK PIECE SPLIT. NO INJURY WAS REPORTED. THE SAMPLE IS BEING RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THIS INVESTIGATION IS ONGOING AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
A VOLUNTARY MEDWATCH REPORT (#MW5151053) WAS RECEIVED ON 02/20/2024 REPORTING A NURSE WENT TO APPLY THE C-COLLAR TO A PATIENT AND THE FRONT NECK PIECE SPLIT. NO INJURY WAS REPORTED. THE SAMPLE WAS RETURNED AND EVALUATED BY THE MANUFACTURING FACILITY. BASED ON THE INVESTIGATION PERFORMED AND THE VERIFICATION OF THE PHYSICAL SAMPLE, THE ROOT CAUSE WAS DETERMINED TO BE AN OPERATOR ERROR. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN TAKEN BY DEROYAL: RETRAINING WAS GIVEN TO INJECTION MOLDING OPERATORS TO MAKE SURE THE ADULT CHIN CUP (PART# PPF0302C) ARE MADE ACCORDING TO THE MANUFACTURING SPECIFICATIONS AND WORK ORDER ROUTING AND NO DEFECTIVE PRODUCT EXIT THE MANUFACTURING PROCESS. RETRAINING WAS GIVEN TO THE PERSONNEL IN CHARGE OF MANUFACTURE THE EMT, CERVICAL COLLARS TO MAKE SURE THAT THE WORK ORDER PROCEDURE (PCD.QLP.049) IS BEING FOLLOWED AND THE PRODUCT IS ASSEMBLED ACCORDING TO THE ROUTING STEPS AND NO DEFECTIVE PARTS ARE BEING USED. AN INVENTORY CHECK OF THE COLLAR WAS MADE BY DEROYAL, A TOTAL OF 32 OF THE 1044-31 CERVICAL COLLAR, EMT SELECT ONE PIECE, ADULT UNIV LOT # 60385985 AND 13 OF THE PPF0302C EXTRICATION COLLAR/ADULT FRONT LOT # 60319531 WERE INSPECTED, AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.