MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for NASOGASTRIC SUMP TUBE W/PREVENT ANTI-REFLEUX FILTER 0046160 manufactured by C.r. Bard, Inc..
[121864973]
Ng tube had been placed for gastric decompression. Rn attempted to administer ct contrast through ng and noted fluid and gastric contents leaking onto patient's gown. Upon examination of ng tube it was found that where the blue ant-reflux tube exited the clear portion of the ng tube that there was an opening that was allowing the escape of fluids being instilled/drained. Enteric tube had to be removed and another ng tube was placed. Manufacturer response for nasogastric sump tube with prevent anti-reflux filter, (brand not provided) (per site reporter). I spoke to bard quality issues. They are sending me shipping material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7913745 |
| MDR Report Key | 7913745 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-08-30 |
| Report Date | 2018-09-07 |
| Date Reported to FDA | 2018-09-07 |
| Date Reported to Mfgr | 2018-09-27 |
| Date Added to Maude | 2018-09-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | NASOGASTRIC SUMP TUBE W/PREVENT ANTI-REFLEUX FILTER |
| Generic Name | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION |
| Product Code | FEG |
| Date Received | 2018-09-27 |
| Model Number | 0046160 |
| Catalog Number | 0046160 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-27 |