MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-06-18 for ANGIODYNAMICS H749601500351 manufactured by Angiodynamics.
[148412320]
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly and performance specifications. The may 2019 angiodynamics complaint report was reviewed for the y-adaptors and convenience kit product families for the failure mode "air bubbles noted. " no adverse trend was identified. Four (loose) y-adaptors were returned for evaluation. A visual inspection was performed on all four of the returned samples. No visible defects were noted. The caps on all four of the returned samples were in the opened position as received. The samples were air leak tested at 20psi of pressure using a heise. All four of the returned samples passed the leak test requirements per angiodynamics' procedures. The caps were able to be tightened and then loosened without difficulty during the leak test. The reported complaint description cannot be confirmed nor can a root cause for the event be determined. The samples were tested and met the visual and functional acceptance criteria as per angiodynamics procedures. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[148412321]
As reported, end user is complaining about the touhy-borst valve on the y-adaptor in their convenience kit letting air into the system. No air has been injected and there has been no patient injury. A used device will be returned to angiodynamics for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00077 |
| MDR Report Key | 8709444 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-06-18 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-05-21 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2019-06-18 |
| 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 | 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 | CONVENIENCE KIT |
| Product Code | OEZ |
| Date Received | 2019-06-18 |
| Returned To Mfg | 2019-05-29 |
| Catalog Number | H749601500351 |
| Lot Number | 5455140 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-06-18 |