MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-02 for BARD? PREVENT? ANTI-REFLUX FILTER 0046000 manufactured by C.r. Bard, Inc. (covington) -1018233.
[137956538]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[137956539]
It was reported that the markings on the ng tube had rubbed off. Without the markings, the nursing staff could not determine where the ng tube was inserted, or where it should be located. Additionally, it was alleged that residue remained in the filters after use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-01121 |
| MDR Report Key | 8384361 |
| Date Received | 2019-03-02 |
| Date of Report | 2019-04-05 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2018-08-02 |
| Date Added to Maude | 2019-03-02 |
| 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? PREVENT? ANTI-REFLUX FILTER |
| Generic Name | FILTERS FOR NG TUBE |
| Product Code | FEG |
| Date Received | 2019-03-02 |
| Catalog Number | 0046000 |
| Lot Number | NGCU2173 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-02 |