MALONEY TUNGSTEN FILLED BOUGIE 36F
Received May 6, 2024 · Event occurred Apr 8, 2024
Report 3004365956-2024-00042 · MDR key 19254509
Device
Generic name
Bougie, Esophageal, And Gastro
Manufacturer
Teleflex MedicalCatalog number
507936
Lot number
UNKNOWN
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4), THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER REPORTED: "BASED ON THE FINDINGS DURING VISUAL INSPECTION TO THE SAMPLE SENT, THE COMPLAINT CANNOT BE CONFIRMED AS A MANUFACTURING DEFECT AS RESIDUE AND MARKS WERE FOUND FROM THE SEALER WHICH IS PLACED OVER THE EXPIRATION DATE TO PROTECT THE STAMPING. ADDITIONALLY, WE DON'T HAVE THE ENOUGH INFORMATION ABOUT THE SUBSTANCE THAT THE CUSTOMER USED TO WASH THE PIECE. HOWEVER, MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS EVENT ON MAY 13, 2024. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED "INSTRUMENT USED BY DATE STAMP HAS COME OFF THE BOUGIE AND CSSD ARE NOW UNABLE TO STERILISE AS UNABLE TO DETERMINE CORRECT USED BY DATE IN ACCORDANCE WITH MANUFACTURING GUIDELINES". NO PATIENT INVOLVEMENT REPORTED.
Additional Manufacturer Narrative
(B)(4) COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED "INSTRUMENT USED BY DATE STAMP HAS COME OFF THE BOUGIE AND CSSD ARE NOW UNABLE TO STERILISE AS UNABLE TO DETERMINE CORRECT USED BY DATE IN ACCORDANCE WITH MANUFACTURING GUIDELINES". NO PATIENT INVOLVEMENT REPORTED.