MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for BARD? PREMATURE INFANT FEEDING TUBE 0036400 manufactured by C.r. Bard, Inc. (covington) -1018233.
[103020597]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[103020598]
It was reported that a patient had been struggling with breastfeeding her baby, attempting multiple times during a nurse's shift. The patient had been set up with a nipple shield, feeding tube and syringe to assist her in feeding her newborn. After multiple attempts to feed the newborn, it was noticed that the newborn was still unable to intake the supplemental formula from the feeding tube and syringe. Upon further inspection of the feeding tube, the nurse noticed that the tube had only one hole at the end of it instead of two. The infant was not able to suck the supplemental formula from the device. Per additional information: the mother was trying to breastfeed and use the device at the same time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00863 |
| MDR Report Key | 7350173 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-04-05 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2017-05-06 |
| Date Added to Maude | 2018-03-19 |
| 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 | AMY GRAVLEY |
| 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? PREMATURE INFANT FEEDING TUBE |
| Generic Name | FEEDING TUBE |
| Product Code | FPD |
| Date Received | 2018-03-19 |
| Model Number | 0036400 |
| Catalog Number | 0036400 |
| Lot Number | NGBR3192 |
| 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 | 2018-03-19 |