ANESTHESIA UNKNOWN PRODUCT CODE
Report
- Report Number
- 8040412-2023-00414
- Event Type
- Malfunction
- Date Received
- December 26, 2023
- Date of Event
- November 30, 2023
- Report Date
- November 30, 2023
- Manufacturer
- TELEFLEX MEDICAL SDN. BHD.
- Product Code
- BTR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4). IN SECTION UNABLE TO PROVIDE FULL UDI AS NO PART NUMBER AND LOT NUMBER WERE REPORTED.**UDI RELATED DATA QUALITY UPDATES ONLY** OTHER REMARKS: N/A CORRECTED DATA: N/A.
QN#(B)(4) THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER REPORTED: "NO SAMPLE WAS RETURNED SO THE VISUAL INSPECTION CANNOT BE CONDUCTED. BASED ON THE CUSTOMER INPUT, THE PROBLEM WAS DUE TO THE WRONG DELIVERY OF PRODUCT AND INCORRECT USAGE OF TUBE DURING THE PROCEDURE. REVIEWING THE MANUFACTURING PROCESS, ALL PRODUCTS WERE SUBJECTED FOR 100% INSPECTION AND WENT THROUGH QA BUY OFF INSPECTION PROCESS. ANY DEFECT NOT MEETING THE SPECIFICATIONS WILL BE CULLED OUT DURING INSPECTION. THERE WAS NO SAMPLE RETURNED FOR INVESTIGATION TO THIS COMPLAINT. THUS, THIS COMPLAINT CANNOT BE CONFIRMED." TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A CORRECTED DATA: N/A.
(B)(4).
THE REPORT STATES, "I ORDERED NASAL RAE TUBES FROM YOUR COMPANY "NASAL SAFETY SILK RUSCHELIT" ITEM NO. 111782 IN SMALL SIZES (3.5;4.0;4.5;5.0) AND APPARENTLY RECEIVED THE ITEM 111781 "RUSCHELIT" IN NOVEMBER. DUE TO A MASSIVE LACK OF STAFF, MY TRAINEE PUT THESE TUBES IN THE DISTRIBUTION LIST FOR THE VARIOUS EXTERNAL OFFICES AND NOBODY NOTICED THIS INCORRECT DELIVERY. NOW THAT THE COMPLAINTS ABOUT MASSIVE NASAL BLEEDING ARE BECOMING MORE FREQUENT, I HAVE ALSO NOTICED THE INCREASED NASAL MASS BLEEDING CAUSED BY THESE HARD TUBES DURING ANESTHESIA OF SMALL CHILDREN. WE OFTEN HAVE TO INSERT NASAL TAMPONADES AFTER ANESTHESIA". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
THE REPORT STATES, "I ORDERED NASAL RAE TUBES FROM YOUR COMPANY "NASAL SAFETY SILK RUSCHELIT" ITEM NO. 111782 IN SMALL SIZES (3.5;4.0;4.5;5.0) AND APPARENTLY RECEIVED THE ITEM 111781 "RUSCHELIT" IN NOVEMBER. DUE TO A MASSIVE LACK OF STAFF, MY TRAINEE PUT THESE TUBES IN THE DISTRIBUTION LIST FOR THE VARIOUS EXTERNAL OFFICES AND NOBODY NOTICED THIS INCORRECT DELIVERY. NOW THAT THE COMPLAINTS ABOUT MASSIVE NASAL BLEEDING ARE BECOMING MORE FREQUENT, I HAVE ALSO NOTICED THE INCREASED NASAL MASS BLEEDING CAUSED BY THESE HARD TUBES DURING ANESTHESIA OF SMALL CHILDREN. WE OFTEN HAVE TO INSERT NASAL TAMPONADES AFTER ANESTHESIA". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
THE REPORT STATES, "I ORDERED NASAL RAE TUBES FROM YOUR COMPANY "NASAL SAFETY SILK RUSCHELIT" ITEM NO. 111782 IN SMALL SIZES (3.5;4.0;4.5;5.0) AND APPARENTLY RECEIVED THE ITEM 111781 "RUSCHELIT" IN NOVEMBER. DUE TO A MASSIVE LACK OF STAFF, MY TRAINEE PUT THESE TUBES IN THE DISTRIBUTION LIST FOR THE VARIOUS EXTERNAL OFFICES AND NOBODY NOTICED THIS INCORRECT DELIVERY. NOW THAT THE COMPLAINTS ABOUT MASSIVE NASAL BLEEDING ARE BECOMING MORE FREQUENT, I HAVE ALSO NOTICED THE INCREASED NASAL MASS BLEEDING CAUSED BY THESE HARD TUBES DURING ANESTHESIA OF SMALL CHILDREN. WE OFTEN HAVE TO INSERT NASAL TAMPONADES AFTER ANESTHESIA". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2266905 | ANESTHESIA UNKNOWN PRODUCT CODE | TUBE, BRONCHIAL (W/WO CONNECT | BTR | TELEFLEX MEDICAL SDN. BHD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |