MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for BARD? ELLIK EVACUATOR 000451 manufactured by C.r. Bard, Inc. (covington) -1018233.
[128196030]
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
[128196031]
It was reported that inside the ellik evacuator packaging, the two adaptors were switched inside the inner packaging. The wolf adaptor was inside the acmi adaptor packaging and the acmi adaptor was inside the wolf adaptor packaging. The adaptors were placed incorrectly on the device due to the mixed adaptors, which caused leakage from the evacuator. The device was replaced and no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-05625 |
| MDR Report Key | 8097207 |
| Date Received | 2018-11-21 |
| Date of Report | 2019-01-09 |
| Date Mfgr Received | 2018-12-23 |
| Device Manufacturer Date | 2018-07-28 |
| Date Added to Maude | 2018-11-21 |
| 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? ELLIK EVACUATOR |
| Generic Name | ELLIK EVACUATOR ADAPTOR |
| Product Code | KQT |
| Date Received | 2018-11-21 |
| Returned To Mfg | 2018-11-08 |
| Model Number | 000451 |
| Catalog Number | 000451 |
| Lot Number | NGCT0773 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-21 |