FDA Adverse Event
Malfunction
Summary report: N
SMALLBORE EXTENSION SET
MDR report key: 3851356
·
Received March 26, 2014
Report
- Report Number
- 9616066-2014-00254
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Report Date
- February 27, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPB
- PMA / PMN Number
- K960280
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S REPORT DATE: 03/26/2014. INTERNAL FILE NO: (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 VISIBLE PINHOLE(S) ON THE EXTENSION TUBING APPROXIMATELY 1 TO 1.5 INCHES FROM THE END OF THE TUBING RESULTING IN FLUID OR BLOOD LEAKING AND SPRAYING WHEN THE NURSE ATTEMPTS TO FLUSH. LEAK WAS OBSERVED AROUND CLAVE/EXTENSION CONNECTION AT BEGINNING OF USE. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176638 | SMALLBORE EXTENSION SET | FPB | CAREFUSION CORPORATION | 20043E | 13066691 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | THERAPY DATE UNK| LIFESHIELD PRIMARY SET: 12662/28, LOT UNK| ANGIOCATH CATHETER: 382533, LOT UNK| HOSPIRA CLAVE: 11956, LOT UNK, THERAPY DATE UNK |