MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-14 for BD ORALPAK? ORAL DOSING DEVICE 990092 manufactured by Becton Dickinson Ind. Cirurgicas Ltda.
[92909847]
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone#: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[92909848]
It was reported before use of the bd oralpak? Oral dosing device one of the packs with 100 units was filled with dirt. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003916417-2017-00076 |
| MDR Report Key | 7028982 |
| Date Received | 2017-11-14 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-10-20 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON IND. CIRURGICAS LTDA |
| Manufacturer Street | 550 RUA CYRO CORREIA PEREIRA |
| Manufacturer City | CURITIBA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD ORALPAK? ORAL DOSING DEVICE |
| Generic Name | ENTERAL SYRINGE |
| Product Code | PNR |
| Date Received | 2017-11-14 |
| Returned To Mfg | 2017-10-13 |
| Catalog Number | 990092 |
| Lot Number | 6140478 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON IND. CIRURGICAS LTDA |
| Manufacturer Address | 550 RUA CYRO CORREIA PEREIRA CURITIBA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-14 |