MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for BD CORNWALL? DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET 305224 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[105395277]
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
[105395278]
It was reported that a bd cornwall? Disposable syringe filling system with tubing set was leaking at the vent port during use. There was no report of exposure, injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2018-00082 |
| MDR Report Key | 7411010 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-03-21 |
| Device Manufacturer Date | 2017-04-27 |
| Date Added to Maude | 2018-04-10 |
| 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 |
| 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 INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO NO. 579 |
| Manufacturer City | NOGALES |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD CORNWALL? DISPOSABLE SYRINGE FILLING SYSTEM W/TUBING SET |
| Generic Name | SYRINGE |
| Product Code | KYX |
| Date Received | 2018-04-10 |
| Returned To Mfg | 2018-04-04 |
| Catalog Number | 305224 |
| Lot Number | 7093584 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Address | PERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-10 |