MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for CALCIUM CHLORIDE 10%, 1000MG/10ML manufactured by Unk.
[176207991]
There is no pt error. It was noted that 2 boxes look almost identical from the same mfr. The products are calcium chloride 10% injection and heparin lock flush 500 units / 5 ml. Both have similar font and both stickers are yellow. There could be potential for syringe mix-ups when unpacking or storing these medications. (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092382 |
| MDR Report Key | 9616226 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| 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 | CALCIUM CHLORIDE 10%, 1000MG/10ML |
| Generic Name | SYRINGE, PISTON |
| Product Code | FMF |
| Date Received | 2020-01-21 |
| Lot Number | C19413 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | HEPARIN LOCK FLUSH |
| Generic Name | HEPARIN, VASCULAR ACCESS FLUSH |
| Product Code | NZW |
| Date Received | 2020-01-21 |
| Lot Number | H119391N |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |