SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM
Received Feb 1, 2023 · Event occurred Sep 5, 2022
Report 0001625425-2023-00952 · MDR key 16277517
Device
Product problems
- No Flow
- Adverse Event Without Identified Device or Use Problem
- No Flow
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Pneumothorax
- Pneumothorax
Narrative
Additional Manufacturer Narrative
THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.
Description of Event or Problem
PATIENT WHO UNDERGOES AN EVACUATING THORACENTESIS ACCORDING TO MEDICAL ORDER, WHEN INTRODUCING THE CATHETER INTO THE PLEURAL SPACE, NO FLUID IS OBTAINED WHEN ASPIRATING, THE DOCTOR VERIFIES THE LOCATION OF THE CATHETER AND IT IS IN THE CORRECT POSITION, REMOVES THE DEVICE AND REASSEMBLES IT , WHEN TRYING TO INTRODUCE IT, THE ULTRASOUND SHOWS ABUNDANT SUBCUTANEOUS EMPHYSEMA IN THE SOFT TISSUES OF THE THORAX, IT IS NOT POSSIBLE TO PASS THE CATHETER BACK TO THE PLEURAL CAVITY. PNEUMOTHORAX IS SUSPECTED.
Additional Manufacturer Narrative
A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS AND NON-CONFORMANCES WERE RECORDED. A REVIEW OF RETURNED PRODUCT FROM THE CUSTOMER WAS PERFORMED. VISUAL INSPECTION OF THE SAMPLE RETURNED FROM THE CUSTOMER FOUND NO DAMAGE TO THE PRODUCT. FUNCTIONAL TESTING OF THE DEVICE RETURNED FROM THE CUSTOMER CONFIRMED THAT GUIDEWIRE 0.035" PASSED THROUGH THE DRAINAGE SKATER TUBE WITHOUT ANY ISSUE. PRODUCT COMPLAINT MODE COULD NOT BE DUPLICATE DURING THE EVALUATION AND THE COMPLAINT WAS NOT CONFIRMED. THE COMPLAINT WAS NOT CONFIRMED, SO NO FURTHER EVALUATION NEEDED AT THIS TIME.
Description of Event or Problem
PATIENT WHO UNDERGOES AN EVACUATING THORACENTESIS ACCORDING TO MEDICAL ORDER, WHEN INTRODUCING THE CATHETER INTO THE PLEURAL SPACE, NO FLUID IS OBTAINED WHEN ASPIRATING, THE DOCTOR VERIFIES THE LOCATION OF THE CATHETER AND IT IS IN THE CORRECT POSITION, REMOVES THE DEVICE AND REASSEMBLES IT , WHEN TRYING TO INTRODUCE IT, THE ULTRASOUND SHOWS ABUNDANT SUBCUTANEOUS EMPHYSEMA IN THE SOFT TISSUES OF THE THORAX, IT IS NOT POSSIBLE TO PASS THE CATHETER BACK TO THE PLEURAL CAVITY. PNEUMOTHORAX IS SUSPECTED.