MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for MONOJECT SYRINGE 35 ML manufactured by Unk.
[178228368]
A monoject 35 ml syringe was used to prepare a dose of carboplatin 150 mg/15 ml (10 mg/ml). During dose verification the pharmacist noticed that the syringe mark for 0 ml was in the wrong place, corresponding to 5 ml of 'extra volume'. As result, a carboplatin dose of 200 mg (20 ml) was originally drawn up into the syringe. Had this error reached the pt it would have resulted in a 33% overdose of the pt's carboplatin. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092819 |
| MDR Report Key | 9677149 |
| Date Received | 2020-02-05 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOJECT SYRINGE 35 ML |
| Generic Name | INSTRUMENT, SURGICAL, DISPOSABLE |
| Product Code | KDC |
| Date Received | 2020-02-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |