FDA Adverse Event
Malfunction
Summary report: N
BARD 3-WAY IRRIGATION FOLEY
MDR report key: 1855360
·
Received September 30, 2010
Report
- Report Number
- MW5017664
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Report Date
- September 30, 2010
- Manufacturer
- BARD
- Product Code
- KOD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT HAD A CONTINUOUS BLADDER IRRIGATION -CBI- ORDERED TO RUN AT A SPECIFIC RATE. THE CBI TUBING IS BARD 3-WAY FOLEY IRRIGATION TUBING. BECAUSE THE IRRIGATION WAS ORDERED TO RUN AT A SPECIFIC RATE, IT NEEDED TO BE INFUSED VIA AN IV PUMP. STAFF ERRONEOUSLY ATTACHED THE B BRAUN IV TUBING TO THE LUMEN OF THE FOLEY CATHETER CONTAINING THE BALLOON. THE BALLOON EVENTUALLY RUPTURED INTERNALLY. PT EXPERIENCED DISCOMFORT AND SEVERE PAIN ON REMOVAL. NO BLOOD OBSERVED. OTHERWISE PT APPEARS TO SUFFER NO ADD'L ILL EFFECTS. TUBING/FOLEY NOT FAULTY OR MALFUNCTIONING. JUST WANTED TO NOTIFY YOU THAT THE TYPE OF CONNECTIONS ALLOWED FOR A MISCONNECTION TO OCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BARD 3-WAY IRRIGATION FOLEY | FOLEY | KOD | BARD | |||
| 2 | B BRAUN HORIZON PUMP IV SET | PUMP IV SET | FPA | B. BRAUN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |