FDA Adverse Event
Injury
Summary report: N
HEMODIALYSIS ACCESS
MDR report key: 23733047
·
Received December 5, 2025
Report
- Report Number
- MW5180067
- Event Type
- Injury
- Date Received
- December 5, 2025
- Report Date
- December 3, 2025
- Manufacturer
- UNK
- Product Code
- SEQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
REPEATED ARTERIAL PRESSURE ALARMS WERE RECEIVED DURING THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE STAFF REALIZED THE PATIENT¿S HD ACCESS (A NON-(B)(6) PRODUCT) WAS CLOTTING OFF. THE PATIENT¿S BLOOD WAS RETURNED. TREATMENT WAS ENDED. THE PATIENT WAS SCHEDULED AT A VASCULAR ACCESS CENTER WHERE THE PATIENT¿S ACCESS WAS DECLOTTED. THE RN CONFIRMED THAT THE PATIENT COMPLETED THIS TREATMENT. DUE TO SCHEDULING, THE PATIENT WENT TO THE HOSPITAL TO COMPLETE THIS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130936 | HEMODIALYSIS ACCESS | COVERED STENT VASCULAR CONNECTOR, HEMODIALYSIS ACCESS CIRCUIT | SEQ | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |