MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for BD LUER TIP CAP, STERILE TRAY 305822 manufactured by Becton Dickinson Medical Systems.
[127866549]
Date of event: unknown. The date received by manufacturer has been used for this field. 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
[127866550]
It was reported with the use of the bd luer tip cap, sterile tray there was an issue with foreign matter. There was no report of injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2018-00800 |
| MDR Report Key | 8085923 |
| Date Received | 2018-11-19 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2015-08-11 |
| Date Added to Maude | 2018-11-19 |
| 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 LUER TIP CAP, STERILE TRAY |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYW |
| Date Received | 2018-11-19 |
| Returned To Mfg | 2018-11-12 |
| Catalog Number | 305822 |
| Lot Number | 5201798 |
| Device Availability | R |
| 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 | 2018-11-19 |