MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-30 for HYSKON manufactured by Kabi Pharmacia.
[21593986]
Current packaging and vial design will not deliver the product quickly to a sterile field. Product is very viscous, therefore withdrawing solution via a syringe and needle on a spike is nearly impossible. Surgical staff are removing metal band and rubber stopper with sterile implements. This could lead to particulate contamination or injury to employees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001320 |
| MDR Report Key | 12398 |
| Date Received | 1994-03-30 |
| Date Added to Maude | 1994-03-31 |
| 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 | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSKON |
| Product Code | LTA |
| Date Received | 1994-03-30 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12398 |
| Manufacturer | KABI PHARMACIA |
| Manufacturer Address | PISCATAWAY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-30 |