MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for UKNOWN NASOGASTRIC TUBE UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[124092490]
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
[124092491]
It was reported that the balloon of the blakemore tube would not deflate. The doctor attempted to force air and then water into the gastric balloon, but it would not go through. The doctor reported that the obstruction was proximal. He cut the tube where the clamp was with a hemostat and the device came out. No medical intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-04827 |
| MDR Report Key | 7973315 |
| Date Received | 2018-10-17 |
| Date of Report | 2019-01-18 |
| Date Mfgr Received | 2019-01-03 |
| Date Added to Maude | 2018-10-17 |
| 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 | UKNOWN NASOGASTRIC TUBE |
| Generic Name | BLAKEMORE TUBE |
| Product Code | BSS |
| Date Received | 2018-10-17 |
| Catalog Number | UNK |
| Lot Number | UNK |
| 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 | 2018-10-17 |