MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for BARD? EAGLE? INFLATION DEVICE 325110 manufactured by C.r. Bard, Inc. (covington) -1018233.
[145228263]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145228264]
It was reported that the eagle inflation device suddenly burst causing the press to fail, the operator's hand was slightly injured. This event occurred during the device's normal first use and a new device was used without issue to complete the procedure. The patient required no medical intervention. It was later reported per additional information from the ibc via email 29 april 2019; due to the rupture of the pressure pump, the operator's hand was stressed and painful. The operator had no wounds or bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-02477 |
| MDR Report Key | 8605311 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-04-22 |
| Date Mfgr Received | 2019-06-20 |
| Device Manufacturer Date | 2018-02-13 |
| Date Added to Maude | 2019-05-13 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD? EAGLE? INFLATION DEVICE |
| Generic Name | EAGLE INFLATION DEVICE |
| Product Code | KOE |
| Date Received | 2019-05-13 |
| Catalog Number | 325110 |
| Lot Number | BMCQFM10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-13 |