FDA Adverse Event
Other
Summary report: N
ALARIS SECONDARY SYRINGE ADAPTER SET
MDR report key: 1289481
·
Received January 14, 2009
Report
- Report Number
- 9616066-2009-00027
- Event Type
- Other
- Date Received
- January 14, 2009
- Report Date
- November 20, 2008
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FPA
- PMA / PMN Number
- K022209
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). THIS REPORT WAS FILED BY THE MANUFACTURER.
Description of Event or Problem · 1
EVENT OCCURRED THE WEEK OF (B) (6) 2008. CUSTOMER REPORTED ON-GOING SECONDARY INFUSION ISSUES ASSOCIATED WITH THE SECONDARY SYRINGE ADMINISTRATION SET. STATED A SECONDARY INTERMITTENT INFUSION WAS HUNG BUT NOTED THAT IT DID NOT INFUSE RESULTING IN AN UNDERINFUSION. NO PATIENT HARM WAS REPORTED AND NO ADDITIONAL EVENT OR PATIENT DETAILS ARE AVAILABLE. THE SYRINGE SECONDARY ADMINISTRATION SET WAS RECEIVED. THE INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SECONDARY SYRINGE ADAPTER SET | FPA | CARDINAL HEALTH ALARIS PRODUCTS | 9996-0000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |