MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-28 for BARD NASOGASTRIC SUMP TUBE manufactured by Bard Medical Inc.
[24368329]
Patient Sequence No: 1, Text Type: N, H10
[24368330]
After confirmed ng tube placement and tube feeds began, a crack was noted in the sump area of the tube. The tube was leaking at interface of ng and sump. As a result, the patient needed another tube placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5038381 |
| MDR Report Key | 5038381 |
| Date Received | 2015-08-28 |
| Date of Report | 2015-08-14 |
| Date of Event | 2015-07-29 |
| Report Date | 2015-08-14 |
| Date Reported to FDA | 2015-08-14 |
| Date Reported to Mfgr | 2015-08-14 |
| Date Added to Maude | 2015-08-28 |
| 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 | 2015-08-28 |
| Lot Number | NGZD4025 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD MEDICAL INC |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-28 |