MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-16 for PRESTO INFLATION DEVICE ID4030 manufactured by Bard Peripheral Vascular, Inc..
[178124275]
The lot number for the malfunction was provided and a lot history review was performed. The devices has been returned for evaluation; the investigation of the reported malfunction is confirmed for crack, leak, and incorrect or inadequate result. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.
Patient Sequence No: 1, Text Type: N, H10
[178124276]
This report summarizes one malfunction. A review of the reported information indicated that model id4030 inflation device allegedly experienced crack, leak, and incorrect or inadequate result. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient was reported as a male weighing (b)(6) kgs whose age was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-00548 |
| MDR Report Key | 9598186 |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-16 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | FOREFRONT MEDICAL TECHNOLOGY |
| Manufacturer City | CHANGZHOU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESTO INFLATION DEVICE |
| Generic Name | INFLATION DEVICE |
| Product Code | MAV |
| Date Received | 2020-01-16 |
| Model Number | ID4030 |
| Catalog Number | ID4030 |
| Lot Number | PID1806152 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |