FDA Adverse Event
Malfunction
Summary report: N
EASY-LOCK DISCONNECT CAP WITH POVIDONE-IODINE
MDR report key: 471137
·
Received July 7, 2003
Report
- Report Number
- 1423500-2003-00697
- Event Type
- Malfunction
- Date Received
- July 7, 2003
- Date of Event
- June 2, 2003
- Report Date
- June 3, 2003
- Manufacturer
- BAXTER HEALTHCARE, LTD.
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
HOME PT (HP) REPORTS THE DISCONNECT CAP WAS POPPING OFF OF THE PT EXTENSION LINE DURING HI-DOSE APD THERAPY. NOTED DURING USE, UPON RETURNING TO COMPLETE THE HP'S NIGHT EXCHANGES. THE HP REPLACED ALL SUPPLIES AND THERAPY WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY OR MEDICAL INTERVENTION REPORTED PER HP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASY-LOCK DISCONNECT CAP WITH POVIDONE-IODINE | DISCONNECT CAP | KDJ | BAXTER HEALTHCARE, LTD. | NA | 02J16H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | LOW CALCIUM DIANEAL SOLUTION, STRENGTH UNK, DATE| 5C4469 - HOMECHOICE AUTOMATED PD SET W/CASSETTE| 5C4480P - 12 FT. EXTENSION SET, EASY LOCK| 5C4471 - HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT,| DATE UNK.| 4-PRONG, DATE UNK.| UNK.| CONNECTOR, DATE UNK. |