FDA Adverse Event
Malfunction
Summary report: N
CLEO® 90 INFUSION SET
MDR report key: 5995110
·
Received October 3, 2016
Report
- Report Number
- 2183502-2016-02181
- Event Type
- Malfunction
- Date Received
- October 3, 2016
- Date of Event
- August 6, 2012
- Report Date
- September 8, 2016
- Manufacturer
- SMITHS MEDICAL ASD INC.
- Product Code
- FPA
- PMA / PMN Number
- K042172
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CLEO® 90 INFUSION SET SITE ADHESIVE WOULD NOT REMAIN ON THE PATIENT'S BODY PAST ONE DAY. THE PATIENT NOTED THAT SHE USED SKIN TAC AND FILM DRESSING AND CONTINUED TO HAVE AN ISSUE SINCE BEGINNING ON A DISTRIBUTOR'S PUMP. NO PATIENT INJURY WAS REPORTED. SEE MFR: 2183502-2016-02180, 2183502-2016-02182, 2183502-2016-02183, 2183502-2016-02184, 2183502-2016-02185, 2183502-2016-02186, 2183502-2016-02187, 2183502-2016-02188, AND 2183502-2016-02189.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 645474 | CLEO® 90 INFUSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |