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 2019-07-12 for ANGIODYNAMICS H7496013022111 manufactured by Angiodynamics.
[150882980]
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 recent angiodynamics complaint report was reviewed for the syringe product family and the failure mode "air bubbles. " no adverse trend was identified. The end user hospital's reported complaint description cannot be confirmed nor can a root cause be established, as no sample was returned. The angiographic syringes are subjected to multiple inspections during production including visual inspections under magnification for molding defects, visual inspection of the male luer locks, and in-process leak testing. ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[150882981]
As reported by hospital, the seal (stopper) on the plunger of the 10ml angiographic syringe packaged within their convenience kit "is not tight and there is wiggle room causing air to get into the system at the back portion of the syringe. " this has been observed during prep. No air has been injected into a patient. No samples have been retained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00087 |
| MDR Report Key | 8786346 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-07-12 |
| Date of Report | 2019-07-12 |
| Date of Event | 2019-06-17 |
| Date Mfgr Received | 2019-06-17 |
| Device Manufacturer Date | 2019-04-29 |
| Date Added to Maude | 2019-07-12 |
| 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 | CONVENIENCE KIT |
| Product Code | OEZ |
| Date Received | 2019-07-12 |
| Catalog Number | H7496013022111 |
| Lot Number | 5465008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-07-12 |