MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for ALL-FILL manufactured by All-fill Inc..
[58060346]
We have been operating a piece of equipment called all fill that operates and fills powder into a bottle. The equipment has been having the issue of passing bad bottles. The equipment should notify the operator if a bottle is out of weight specifications with a red light and a green light if it is good. We have caught on 4 separate occasions that the equipment is passing bottles 1 gram heavier than specifications with a green light. Management has done no corrective action to the equipment to fix the issue and quite possibly giving patients a bad product or stronger dosage then what is on the label. Name of the product as it appears on the box, bottle, or package: fluconazole for oral suspension. Name of the company that makes (or compounds) the product: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065483 |
| MDR Report Key | 6039466 |
| Date Received | 2016-10-17 |
| Date of Report | 2016-10-17 |
| Date of Event | 2016-10-11 |
| Date Added to Maude | 2016-10-19 |
| 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 | 0 |
| Brand Name | ALL-FILL |
| Generic Name | MEDICATION DISPENSER |
| Product Code | NXB |
| Date Received | 2016-10-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALL-FILL INC. |
| Manufacturer Address | EXTON PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-17 |