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 2019-01-10 for BD? SYRINGE TIP CAP 305819 manufactured by Bd Medical (bd West) Medical Surgical.
[132623537]
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 7200661. Medical device expiration date: 2022-09-30. Device manufacture date: 2017-07-19. Medical device lot #: 8207911. Medical device expiration date: 2023-06-30. Device manufacture date: 2018-07-26. 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
[132623538]
It was reported with the use of the bd? Syringe tip cap there were 2 issues with leakage from the seal between the cap and the syringe, once with lot# 7200661 and once with 8207911.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00834 |
| MDR Report Key | 8233225 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2019-01-10 |
| Date of Report | 2019-02-21 |
| Date of Event | 2018-12-21 |
| Date Mfgr Received | 2018-12-21 |
| Date Added to Maude | 2019-01-10 |
| 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 | 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 | 3 |
| Brand Name | BD? SYRINGE TIP CAP |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYW |
| Date Received | 2019-01-10 |
| Catalog Number | 305819 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| 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 | 2019-01-10 |