FDA Adverse Event
Malfunction
Summary report: N
CURLIN ADMINISTRATION SET
MDR report key: 2190590
·
Received July 27, 2011
Report
- Report Number
- 1722139-2011-00153
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- MOOG MEDICAL DEVICES GROUP
- Product Code
- FRN
- Removal / Correction Number
- Z-1444-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
PRODUCT 340-4128, LOT NO. CRF10155003 IS CURRENTLY UNDER RECAL #Z-1444-2011.
Description of Event or Problem · 1
INFO RECEIVED ALLEGES THE PT IS CONSTANTLY FINDING BUBBLES IN THE SOFT TUBING SEGMENT UP TO AN INCH LONG. THE UNIT PRIMES WELL BUT NEW AIR KEEPS REAPPEARING. PT HAS DIFFICULTY RIDDING TUBING OF AIR. THE PUMP KEEPS BEEPING AIR IN LINE ALL NIGHT LONG. THIS ALLEGEDLY HAPPENED TO ONE PT 2 TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURLIN ADMINISTRATION SET | FRN | MOOG MEDICAL DEVICES GROUP | 340-4128 | CRF10155003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CURLIN INFUSION PUMP |