MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for BARD? NASOGASTRIC SUMP TUBE 0042160 manufactured by C. R. Bard, Inc..
[73255386]
Patient Sequence No: 1, Text Type: N, H10
[73255387]
The patient underwent surgery for placement of a gastric feeding tube in (b)(6). The following day, the patient was required to return to surgery because the feeding tube came dislodged. The attending physician believed that the portion of the balloon where there is glue seemed as if it had peeled off and flipped on itself, thus deflating the balloon and causing it to fall out of the patient. The device has been reported and returned to the manufacturer for failure analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6507085 |
| MDR Report Key | 6507085 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-14 |
| Date of Event | 2017-03-23 |
| Report Date | 2017-04-14 |
| Date Reported to FDA | 2017-04-14 |
| Date Reported to Mfgr | 2017-04-14 |
| Date Added to Maude | 2017-04-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? NASOGASTRIC SUMP TUBE |
| Generic Name | TUBE, NASOGASTRIC |
| Product Code | BSS |
| Date Received | 2017-04-20 |
| Returned To Mfg | 2017-04-12 |
| Model Number | 0042160 |
| Catalog Number | 0042160 |
| Lot Number | NGAW1092 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C. R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BOULEVARD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |