FDA Adverse Event
Malfunction
Summary report: N
PALL "LIPIPOR" NLF FILTER W/FEMALE LUER INSLET 25 CM LONG DOWNSTREAM TUBING WITH
MDR report key: 1772377
·
Received July 28, 2010
Report
- Report Number
- 9680602-2009-00005
- Event Type
- Malfunction
- Date Received
- July 28, 2010
- Date of Event
- October 17, 2009
- Report Date
- October 26, 2009
- Manufacturer
- PALL NEWQUAY
- Product Code
- FPB
- PMA / PMN Number
- K905794
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS RECEIVING TOTAL PARENTERAL NUTRITION FLUID THOUGH AN INTRAVENOUS LINE CONTAINING THE DEVICE, WHEN LEAKAGE WAS DISCOVERED, APPEARING IN THE BED NEAR THE DEVICE. THERE WAS A BLOCKAGE IN THE INFUSION CATHETER. THE LENGTH OF TIME BETWEEN THE BLOCKAGE OF FLOW/LEAK AND THE ATTENDING STAFF'S DISCOVERY OF THE EVENT WAS NOT DETERMINED. NO ADVERSE SEQUELAE HAVE BEEN REPORTED FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALL "LIPIPOR" NLF FILTER W/FEMALE LUER INSLET 25 CM LONG DOWNSTREAM TUBING WITH | PALL "LIPIPOR" NLF FILTER | FPB | PALL NEWQUAY | NLF2E | 09-187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |