MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-04-27 for BARD? NASOGASTRIC SUMP TUBE 0042160 manufactured by Productos Para El Cuidado De La Salud -9611590.
[73853639]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[73853640]
It was reported that after the nasogastric (ng) tube was placed, the patient went home and the ng tube became dislodged the day after. The patient allegedly went back to the hospital to have an additional surgery to replace the ng tube. The attending physician believed that the portion of the balloon where there was glue seemed as if it had peeled off and flipped on itself; deflating the balloon and causing it to fall out.
Patient Sequence No: 1, Text Type: D, B5
[75643533]
Upon further review, bard medical has determined that this mdr was initially reported in error as per additional information received the alleged device is not sold by bard medical. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[75643534]
It was reported that after the nasogastric (ng) tube was placed, the patient went home and the ng tube became dislodged the day after. The patient allegedly went back to the hospital to have an additional surgery to replace the ng tube. The attending physician believed that the portion of the balloon where there was glue seemed as if it had peeled off and flipped on itself; deflating the balloon and causing it to fall out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-02149 |
| MDR Report Key | 6526861 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-04-27 |
| Date of Report | 2017-05-10 |
| Date of Event | 2017-03-23 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-04-27 |
| 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 | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Street | KM. 7 CARRETERA INTERNACIONAL |
| Manufacturer City | NOGALES, SONORA 85621 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 85621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? NASOGASTRIC SUMP TUBE |
| Generic Name | NG TUBE |
| Product Code | BSS |
| Date Received | 2017-04-27 |
| Catalog Number | 0042160 |
| Lot Number | NGAW1092 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 |
| Manufacturer Address | KM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-04-27 |