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 |