MALONEY TUNGSTEN FILLED BOUGIE 32F
Received Jul 11, 2023 · Event occurred Jun 12, 2023
Report 3004365956-2023-00049 · MDR key 17298767
Device
Generic name
Bougie, Esophageal, And Gastro
Manufacturer
Teleflex MedicalModel number
IPN029212Catalog number
507932
Lot number
UNKNOWN
Product problems
- Delivered as Unsterile Product
- Delivered as Unsterile Product
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE IT WAS FOUND THAT "SPOTS" WERE FOUND ALL OVER THE DEVICE. NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
QN # (B)(4). THE SAMPLE WAS RETURNED BY THE CUSTOMER AND SENT TO THE MANUFACTURING SITE FOR INVESTIGATION. THE MANUFACTURING SITE REPORTS "DURING THE VISUAL INSPECTION IT CAN BE OBSERVED THE CARTON TUBE SHOW SIGNS OF CONTAMINATION AND DAMAGE. ALSO, THE BOUGIE HAVE CONTAMINATION THROUGH THE BODY." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER OF THE RETURNED SAMPLE AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE MANUFACTURING SITE CONCLUSION: "PER VISUAL INSPECTION RESULTS, THE CONDITION REPORTED AS "SPOTS ON THE PRODUCT" CANNOT BE CONFIRMED DUE THE CONDITION IN WHICH THE MATERIAL WAS RECEIVED. IN ADDITIONAL ACCORDING TO THE REVISION OF THE DHR (DEVICE HISTORY RECORD) NO DISCREPANCIES WERE FOUND ON THE MANUFACTURING OF THIS PRODUCT, NO TOOLS ARE USED IN THE MANUFACTURING AND INSPECTION PROCESS THAT CAN GENERATE OR BE RELATED WITH THE CONDITION REPORTED. THE FOLLOWING ACTIVITIES TOOK PLACE: MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS EVENT ON JULY 25TH, 2023." OTHER REMARKS: N/A CORRECTED DATA: N/A.
Additional Manufacturer Narrative
QN# (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT PRIOR TO USE IT WAS FOUND THAT "SPOTS" WERE FOUND ALL OVER THE DEVICE. NO PATIENT INVOLVEMENT.