MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-20 for ANGIODYNAMICS H965601910111 manufactured by Angiodynamics.
[145487194]
It has been indicated that used and unused device samples will be returned for evaluation, however they have not yet arrived. A supplemental medwatch will be submitted upon completion of the investigation. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[145487195]
As reported, with a convenience kit, air bubbles were believed to be entering the line at the connection of the disposable transducer and the pressure monitoring line. "the connections were then tightened, and eventually changed out. " no air was injected and there was no patient injury. Samples are being returned to angiodynamics for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00067 |
| MDR Report Key | 8623260 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-20 |
| Date of Report | 2019-08-13 |
| Date Mfgr Received | 2019-04-26 |
| Device Manufacturer Date | 2019-03-20 |
| Date Added to Maude | 2019-05-20 |
| 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 | MR. LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIODYNAMICS |
| Generic Name | CARDIOVASCULAR PROCEUDRE KIT |
| Product Code | OEZ |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-07-09 |
| Catalog Number | H965601910111 |
| Lot Number | 5450161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |