MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-16 for BD CORNWALL? DISPOSABLE SYRINGE FILLING SYSTEM WITH TUBING SET 305224 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[105882674]
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
[105882675]
It was reported that the 10 ml bd cornwall? Disposable syringe filling system with tubing set was found leaking at the vent port during use. There was no report of exposure, serious injury or medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2018-00084 |
| MDR Report Key | 7434840 |
| Date Received | 2018-04-16 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-03-22 |
| Date Mfgr Received | 2018-03-22 |
| Device Manufacturer Date | 2017-04-27 |
| Date Added to Maude | 2018-04-16 |
| 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 WITH TUBING SET |
| Generic Name | LIQUID MEDICATION DISPENSER |
| Product Code | KYX |
| Date Received | 2018-04-16 |
| 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 | 2018-04-16 |