DRAINS MINI-EXPRESS
Report
- Report Number
- 3011175548-2024-00064
- Event Type
- Malfunction
- Date Received
- February 15, 2024
- Date of Event
- February 10, 2024
- Report Date
- March 26, 2024
- Manufacturer
- ATRIUM MEDICAL CORPORATION
- Product Code
- KDQ
- UDI-DI
- 00650862164008
- PMA / PMN Number
- K984496
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED.
INVESTIGATION SUMMARY: THE INFORMATION PROVIDED STATED THAT THE ED NURSE CALLED ABOUT AN EXPRESS MINI 500 DRAIN ON A PATIENT THAT HAD JUST COME INTO THE ED. HE SAID THE SAMPLE PORT WAS CLOGGED. THE PATIENT HAD BEEN HOME WITH THE DRAIN AND CAME INTO THE ED TO HAVE IT CHANGED. HOWEVER, THE HOSPITAL DOES NOT HAVE THIS DRAIN IN STOCK. TYLER SAID HE JUST DISCOVERED THEY DIDN¿T CARRY IT AT THE TIME OF MY CALL BACK. HE SAID THE PATIENT HAS AN APPOINTMENT ON MONDAY AND WILL HAVE IT CHANGED THEN. THE LOT NUMBER FOR THIS DEVICE WAS NOT PROVIDED SO A DHR REVIEW CANNOT BE COMPLETED AND NCRS AND INCOMING INSPECTION RECORDS INVOLVING THESE DEVICES CANNOT BE REVIEWED. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR THE USE OF THE DEVICE. IT WARNS THE USER NOT TO USE THIS DRAIN IF FLUID DRAINAGE IS EXPECTED TO EXCEED 500ML PER DAY AND NOT TO ATTEMPT TO REUSE THE DEVICE. IT ALSO CAUTIONS THE USER TO REPLACE THE DEVICE ONCE ITS COLLECTION VOLUME REACHES MAX CAPACITY. IT STATES THAT THE DRAIN SHOULD ONLY BE USED BY A HEALTHCARE PROVIDER AND THAT THE DRAIN SHOULD NOT BE EMPTIED. A FIELD NOTIFICATION WAS SENT TO ATRIUM CUSTOMERS ON (B)(6) 2023 WITH ADDITIONAL INSTRUCTIONS THAT THE DRAIN IS RESTRICTED FOR USE IN A HEALTHCARE FACILITY AND THAT THE DRAIN SHOULD NOT BE EMPTIED. A COMPLAINT HISTORY REVIEW WAS COMPLETED WHICH FOUND (B)(4) SIMILAR COMPLAINTS INVOLVING OUTPATIENT USE. A RECURRING LOT NUMBER REPORT COULD NOT BE COMPLETED WITHOUT THE LOT NUMBER. A REVIEW OF CRS/CAPAS FOUND (B)(4) RELATED CRS AND (B)(4) RELATED CAPAS IN THE TWO YEARS PRIOR TO THIS EVENT. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THIS COMPLAINT IS RELATED TO MANUFACTURING, MATERIALS, OR DESIGN OF THE DEVICE. THE HAZARDOUS SITUATION/HARMS IS ADDRESSED IN THE HARM HAZARDS ANALYSIS DOCUMENT WHICH ASSIGNS THE REPORTED DEFECT A SEVERITY LEVEL OF 1. THIS WAS DETERMINED TO BE APPROPRIATE BASED ON THE HARM THAT WAS REPORTED IN THE COMPLAINT. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINT AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT CAN BE CONFIRMED, HOWEVER A DEVICE NONCONFORMANCE CANNOT. THE INFORMATION PROVIDED INDICATES THAT THE DEVICE WAS USED OUTSIDE THE INTENDED ENVIRONMENT AND IN A WAY THAT WAS NOT INTENDED. EMPTYING AND CONTINUING TO USE THE DRAIN IS NOT RECOMMENDED. USE OF THE DRAIN BY SOMEONE WHO IS NOT A MEDICAL PROFESSIONAL IS NOT RECOMMENDED. PEOPLE WHO ARE NOT MEDICAL PROFESSIONALS ARE NOT EXPECTED TO KNOW HOW TO OPERATE OR INTERPRET THE DRAIN. THE FIELD SAFETY NOTIFICATION AND THE INTERIM LABEL MAKE IT CLEAR THAT THE DEVICE IS NOT INTENDED FOR OUTPATIENT USE. THE ROOT-CAUSE OF THIS COMPLAINT IS USER ERROR, DUE TO OUTPATIENT USE OF THE DRAIN.
EMERGENCY DEPARTMENT NURSE CALLED ABOUT AN EXPRESS MINI 500 DRAIN ON A PATIENT THAT HAD JUST COME INTO THE EMERGENCY DEPARTMENT. HE SAID THE SAMPLE PORT WAS CLOGGED. THE PATIENT HAD BEEN HOME WITH THE DRAIN AND CAME INTO THE ED TO HAVE IT CHANGED. HOWEVER, THE HOSPITAL DOES NOT HAVE THIS DRAIN IN STOCK. TYLER SAID HE JUST DISCOVERED THEY DIDN¿T CARRY IT AT THE TIME OF MY CALL BACK. HE SAID THE PATIENT HAS AN APPOINTMENT ON MONDAY AND WILL HAVE IT CHANGED THEN. NO HARM TO PATIENT.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504053 | DRAINS MINI-EXPRESS | BOTTLE, COLLECTION, VACUUM | KDQ | ATRIUM MEDICAL CORPORATION | 16400 | 00650862164008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | UNKNOWN. |