MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2019-04-25 for BD? ORAL SYRINGE WITH TIP CAP 305209 manufactured by Becton Dickinson Medical Systems.
[147197923]
(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
[147197924]
It was reported that bd? Oral syringe with tip cap had foreign matter in the syringe. No serious injury or medical intervention was reported. The following information was provided by the initial reporter: extra white knob in the syringe. 04/23 information received regarding defect: the extra knob is located in the body of syringe and not in the part where you extract injection liquid. This is the best info i have.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00472 |
| MDR Report Key | 8549226 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2019-04-25 |
| Date of Report | 2019-06-17 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-07-02 |
| Date Added to Maude | 2019-04-25 |
| 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 | 3 |
| Brand Name | BD? ORAL SYRINGE WITH TIP CAP |
| Generic Name | ORAL SYRINGE |
| Product Code | KYW |
| Date Received | 2019-04-25 |
| Catalog Number | 305209 |
| Lot Number | 8183923 |
| 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 | 2019-04-25 |