NI Adverse Event — Injury (MDR 1416980-2020-02412)
NI Adverse Event — Injury (MDR 1416980-2020-02412) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: NI; Generic name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE; Manufacturer: BAXTER HEALTHCARE CORPORATION.
| Device | NI |
|---|---|
| Generic name | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Report number | 1416980-2020-02412 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. |
| Source | openFDA MAUDE (device adverse events) |
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