FDA Adverse Event
Malfunction
Summary report: N
SMALLBORE EXTENSION SET
MDR report key: 4160995
·
Received July 23, 2014
Report
- Report Number
- 9616066-2014-00675
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Report Date
- June 25, 2014
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K061285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED CRACKED FEMALE LUER ON THE T-CONNECTOR. NO PT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PT/EVENT INFO WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430753 | SMALLBORE EXTENSION SET | IV EXTENSION SET | FPA | CAREFUSION CORP. | 20041E | 11075370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO |