MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for BERRY AMBER PLASTIC VIALS manufactured by Berry Global.
[103972462]
Berry amber plastic vials dram 12 - used in prescription filling lids do not have the plastic inserts in them. Some are broken with plastic inserts in them. Very poor quality lids. Cannot be used/ would not be safe to use. Upc barcode: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076204 |
| MDR Report Key | 7380874 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-26 |
| Date of Event | 2018-03-23 |
| Date Added to Maude | 2018-03-29 |
| 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 | PHARMACIST |
| 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 | BERRY AMBER PLASTIC VIALS |
| Generic Name | DISPENSER, SOLID MEDICATION |
| Product Code | NXB |
| Date Received | 2018-03-28 |
| Lot Number | 79117951 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERRY GLOBAL |
| Manufacturer Address | PO BOX 959 EVANSVILLE IN 477060959 US 477060959 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-28 |