MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for BD LUER TIP CAP, STERILE TRAY 305822 manufactured by Becton Dickinson And Company.
[127219225]
A foreign object can be seen inside the packaging of a sterile syringe cap. This is actually the 2nd pack that a person in pharmacy experienced this. The first time, the pack was tossed out. This time, the pack was saved and is available for inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8072988 |
| MDR Report Key | 8072988 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-10-31 |
| Report Date | 2018-11-08 |
| Date Reported to FDA | 2018-11-08 |
| Date Reported to Mfgr | 2018-11-15 |
| Date Added to Maude | 2018-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD LUER TIP CAP, STERILE TRAY |
| Generic Name | CONTAINER, LIQUID MEDICATION, GRADUATED |
| Product Code | KYW |
| Date Received | 2018-11-15 |
| Catalog Number | 305822 |
| Lot Number | 8149998 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |