MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for BD?? ORAL SYRINGE WITH TIP CAP 305210 manufactured by Becton Dickinson Medical Systems.
[134447172]
Date of event: unknown. The date received by manufacturer has been used for this field. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8236737. Medical device expiration date: n/a. Device manufacture date: 2018-08-24. Medical device lot #: 8263592. Medical device expiration date: n/a. Device manufacture date: 2018-09-20. Medical device lot #: 8263594. Medical device expiration date: n/a. Device manufacture date: 2018-09-20. Medical device lot #: 8263595. Medical device expiration date: n/a. Device manufacture date: 2018-09-20. (b)(6). 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
[134447173]
It was reported that before use of the bd? Oral syringe with tip cap plunger rods were broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213809-2019-00128 |
| MDR Report Key | 8287380 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-02-15 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-09 |
| Date Added to Maude | 2019-01-29 |
| 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?? ORAL SYRINGE WITH TIP CAP |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYW |
| Date Received | 2019-01-29 |
| Catalog Number | 305210 |
| Lot Number | SEE H.10 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-29 |