MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-25 for STOPCOCK ZMC7401 manufactured by Baxter Healthcare Corporation.
[180832862]
The actual device was not available; therefore a device analysis could not be completed for that sample. However, six (6) retention samples were evaluated. Visual inspection was performed through the packaging and no issues were noted with the white knob. The reported condition was not verified on the retention samples. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[180832863]
It was reported that the "knob" of a stopcock was loose during patient use. No leakage was reported. There was no patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2020-00972 |
| MDR Report Key | 9751554 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-02-02 |
| Device Manufacturer Date | 2019-03-21 |
| Date Added to Maude | 2020-02-25 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - MALTA |
| Manufacturer Street | A47 INDUSTRIAL ESTATE |
| Manufacturer City | MARSA |
| Manufacturer Country | MT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOPCOCK |
| Generic Name | STOPCOCK, I.V. SET |
| Product Code | FMG |
| Date Received | 2020-02-25 |
| Model Number | NA |
| Catalog Number | ZMC7401 |
| Lot Number | 19C08V105 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |