BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM
Report
- Report Number
- 8030647-2025-00018
- Event Type
- Malfunction
- Date Received
- February 19, 2025
- Report Date
- May 10, 2025
- Manufacturer
- AVANOS MEDICAL INC.
- Product Code
- BSY
- UDI-DI
- 00609038924816
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- 003
Narratives
CORRECTION: G1. ADDITIONAL INFORMATION: D4; H6. THE DEVICE HISTORY RECORD FOR LOT 30269237 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. A PROCESS REVIEW WAS PERFORMED FOR SIMILARLY REPORTED EVENTS AND AN INVESTIGATION WAS CONDUCTED. THE INVESTIGATION RESULTS DETERMINED THE ROOT CAUSE WAS TRACED TO WORN EQUIPMENT DURING THE MANUFACTURING PROCESS. PREVENTATIVE MEASURES HAVE BEEN PUT IN PLACE TO PREVENT THIS ISSUE FROM RECURRING IN THE FUTURE WHICH INCLUDE, VERIFICATION OF THE CORRECT OPERATION OF SENSORS ON THE EQUIPMENT AND VERIFICATION OF PROPER LOCATIONS OF THE EQUIPMENT CAMS DURING PREVENTIVE MAINTENANCE. THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION; WITHOUT A SAMPLE TO PERFORM FUNCTIONAL EVALUATION, THE ROOT CAUSE FOR THE EVENT AS REPORTED COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF MAY 10, 2025, HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2025-00016 FOR THE FIRST REPORT. REFER TO 8030647-2025-00017 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2025-00016 FOR THE FIRST REPORT. REFER TO 8030647-2025-00017 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42474 | BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM | TURBO-CLEANING CLOSED SUCTION CATHETER, T-PIECE, | BSY | AVANOS MEDICAL INC. | 92481 | 30269237 | 00609038924816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |