PORTEX TUBES BLUSELECT SUCTIONAID
Received Jun 3, 2025 · Event occurred May 1, 2025
Report 3012307300-2025-06534 · MDR key 22135773
Device
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
NA · Unknown
- Hypoxia
- Hypoxia
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.
Description of Event or Problem
AN EMAIL WAS RECEIVED REGARDING A PORTEX TRACHEOSTOMY, WITH UNKNOWN ITEM AND LOT NUMBER. IT WAS REPORTED THAT THERE WAS A SPLIT SUBGLOTTIC ASPIRATION PORT ON THE TRACHEOSTOMY TUBE. IT WAS THE SECOND OCCURRENCE SPLIT PORTEX BLUSELECT 7.5 SUBGLOTTIC ASPIRATION PORT IN THE PAST WEEK, AT THE SAME HOSPITAL. BOTH WERE PATIENTS IMPORTED FROM OTHER HOSPITALS. ASSOCIATED TRACHEOSTOMY TUBE COMPLAINT ON (B)(4).
Additional Manufacturer Narrative
D3 - MFG ESTABLISHMENT NAME AND H6. CODES: UPDATED. NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.