FDA Adverse Event
Malfunction
Summary report: N
GRAVITY ADMINISTRATION SET
MDR report key: 4230480
·
Received October 22, 2014
Report
- Report Number
- 9616066-2014-01015
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Report Date
- September 24, 2014
- Manufacturer
- CAREFUSION CORPORATOIN
- Product Code
- FPA
- PMA / PMN Number
- K931173
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS FILED BY THE MANUFACTURER. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL BE NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTS IN THE OR, THE TUBING DISCONNECTED AT ONE OF THE THREE CONNECTION WITHIN THE IV TUBING AND ALL THE ANESTHESIA INDUCTION MEDICATIONS RAN OT ONTO THE FLOOR. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 670977 | GRAVITY ADMINISTRATION SET | IV INFUSION SET | FPA | CAREFUSION CORPORATOIN | C42013E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | MAXPLUS CONNECTOR: MODEL/LOT UNK |