MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for BD? ORAL DISPENSING SYRINGE 3 ML 305220 manufactured by Becton Dickinson Medical Systems.
[147202283]
(b)(6). Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[147202284]
It was reported that bd? Oral dispensing syringe 3 ml scale markings are easily erased. The following information was provided by the initial reporter: they are reviewing the first batch that has arrived from the new plastic syringes that the customer are going to include in their "risperidone solution cases" and they have detected that the ink is very easily erased when handling them. They have erased the ink completely without too much effort. Units: 50000 oral syringe 3 ml clear ref. 305220. Delivery: april 30, 2019. They sampled 315 units. The problem is that the ink is easily erased on all of them, since they all have the same ink impression. The lot we have received is 50000 units.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00577 |
| MDR Report Key | 8654732 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-05-15 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2019-05-30 |
| 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 | 8015652341 |
| 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 | 2019-05-30 |
| Catalog Number | 305220 |
| Lot Number | 8354820 |
| 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 | 2019-05-30 |