MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for BD? LUER LOCK TIP CAP 305819 manufactured by Bd Medical (bd West) Medical Surgical.
[103286686]
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 and/or device history review, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[103286687]
It was reported that several bd? Luer lock tip cap(s) were not sealed properly and fell out of their packages. There was no report of exposure, injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00112 |
| MDR Report Key | 7357392 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-02-28 |
| Date Mfgr Received | 2018-02-28 |
| Device Manufacturer Date | 2016-02-24 |
| Date Added to Maude | 2018-03-21 |
| 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 |
| 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 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD? LUER LOCK TIP CAP |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYX |
| Date Received | 2018-03-21 |
| Catalog Number | 305819 |
| Lot Number | 6055985 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-21 |