FDA Adverse Event
Malfunction
Summary report: N
4 LEAD NEWTON IQ SET
MDR report key: 2945203
·
Received January 31, 2013
Report
- Report Number
- 8030665-2013-00069
- Event Type
- Malfunction
- Date Received
- January 31, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 4, 2013
- Manufacturer
- REYNOSA MANUFACTURING
- Product Code
- KDJ
- PMA / PMN Number
- K904806
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE PT LINE DURING TREATMENT. THE TUBING WAS OBSERVED TO BE CRACKED AT THE CONNECTOR TO THE PT LINE. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION AND THERE IS NO PT ILL EFFECT. SAMPLE WAS DISCARDED BY PT'S MOTHER; SAMPLE IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42268 | 4 LEAD NEWTON IQ SET | NEWTON IQ DIALYSIS CYCLER TUBING | KDJ | REYNOSA MANUFACTURING | 12LR08107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | NEWTON IQ DIALYSIS CYCLER |