FDA Adverse Event
Injury
Summary report: N
BD ALARIS PUMP INFUSION SET- BACK CHECK VALVE
MDR report key: 16664474
·
Received March 31, 2023
Report
- Report Number
- MW5116222
- Event Type
- Injury
- Date Received
- March 31, 2023
- Date of Event
- March 24, 2023
- Report Date
- March 29, 2023
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FPA
- UDI-DI
- 07613203020992
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MED SURG RN DISCONNECTED A PRIMARY INTRAVENOUS TUBING LINE FROM THE MEDI-PORT CONNECTION PORT EXERTING REGULAR EFFORT. THE TIP OF THE PRIMARY TUBING LINE BROKE OFF AND GOT STUCK IN THE CONNECTION HUB. PRIMARY RN HAD TO REPLACE THE MEDI-PORT ACCESS TO ENSURE THAT THE PORT CAN BE INFUSED WITH MEDICATION AND NO PLASTIC FRAGMENTS WERE LEFT THAT CAN COMPROMISE CLEANLINESS OF THE CONNECTION. CENTRAL SUPPLY MANAGER AND RISK MANAGEMENT MADE AWARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1250952 | BD ALARIS PUMP INFUSION SET- BACK CHECK VALVE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON DICKINSON AND COMPANY | 2426-0500 | (10)23013192 | 07613203020992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |