BIOFLO DURAMAX
Report
- Report Number
- 3011642792-2025-00053
- Event Type
- Malfunction
- Date Received
- April 25, 2025
- Date of Event
- March 21, 2025
- Report Date
- March 31, 2026
- Manufacturer
- MERIT MEDICAL SYSTEMS INC.
- Product Code
- MSD
- UDI-DI
- 00884450786215
- PMA / PMN Number
- K131260
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND.
D1, D2, D3 AND D4 CORRECTED PRODUCT INFORMATION AND MANUFACTURER ADDRESS. D9 UPDATED. G1 CORRECTED MANUFACTURING SITE FOR DEVICES ADDRESS. G4 CORRECTED PMA/510(K) NUMBER. H4 ADDED DATE. H10 ADDED RELATED REPORT NUMBERS. H11 PRODUCT EVALUATION. THE CUSTOMER RETURNED AN UNOPENED BIOFLO DURAMAX TRAY PART NUMBER H965103028030 (ACCORDING TO POUCH LABEL) AND LOT NUMBER 5810281 FOR INVESTIGATION DUE TO THE TEAR-AWAY SHEATH NOT BEING PROPERLY TRIMMED. UPON A VISUAL INSPECTION OF THE RETURNED UNIT, NO DAMAGES WERE OBSERVED. THE SPLIT TEST WAS PERFORMED ON THE DPRO SHEATH AND THE SHEATH SPLIT EVENLY. THE DEVICE PERFORMED AS INTENDED. SINCE THE SHEATH ARRIVED IN INTACT CONDITION, SPLITTED AND PERFORMED AS INTENDED, THEREFORE THE ROOT CAUSE REMAINS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268790 | BIOFLO DURAMAX | CATHETER, HEMODIALYSIS, IMPLANTED | MSD | MERIT MEDICAL SYSTEMS INC. | 00884450786215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |