IAB: 8 FR 40 CC Adverse Event — Malfunction (MDR 1219856-2008-00051)
IAB: 8 FR 40 CC Adverse Event — Malfunction (MDR 1219856-2008-00051) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: IAB: 8 FR 40 CC; Generic name: INTRA-AORTIC BALLOON PRODUCTS; Manufacturer: ARROW INTL., INC..
| Device | IAB: 8 FR 40 CC |
|---|---|
| Generic name | INTRA-AORTIC BALLOON PRODUCTS |
| Manufacturer | ARROW INTL., INC. |
| Report number | 1219856-2008-00051 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional |
| Narrative | THIS REPORT WAS SENT VIA A "CALL REPORT;" IT WAS REPORTED THAT THE NURSE STATED TO THE CLINICAL SUPPORT SPECIALIST (CSS) THAT THE SIX INCH EXTENSION WITH THE 3 WAY STOPCOCK WAS LEAKING AT THE "END WHERE YOU PUT THE SYRINGE." THE CSS CONFIRMED WITH THE NURSE THAT THE LEAK WAS AT THE STOPCOCK END. THE CSS EXPLAINED THAT THEY COULD USE A GENERIC EXTENSION AND STOPCOCK. THE NURSE WAS ASKED TO SAVE THE |
| Source | openFDA MAUDE (device adverse events) |
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