MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for BD? ORAL DISPENSING SYRINGE 3 ML 305220 manufactured by Becton Dickinson Medical Systems.
[130324763]
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
[130324764]
It was reported that bags for the bd? Oral dispensing syringe 3 ml had no lot number identification on them.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2018-00900 |
| MDR Report Key | 8156205 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MEDICAL SYSTEMS |
| Manufacturer Street | ROUTE 7 AND GRACE WAY |
| Manufacturer City | CANAAN CT 06018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06018 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? ORAL DISPENSING SYRINGE 3 ML |
| Generic Name | ORAL SYRINGE |
| Product Code | KYW |
| Date Received | 2018-12-12 |
| Catalog Number | 305220 |
| Lot Number | UNKNOWN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL SYSTEMS |
| Manufacturer Address | ROUTE 7 AND GRACE WAY CANAAN CT 06018 US 06018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-12 |