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 2017-12-07 for NASOGASTRIC SUMP TUBE DUAL LUMEN UNK manufactured by C.r. Bard, Inc. (covington) -1018233.
[94067512]
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The product family for this nasogastric tube product is unknown. Therefore, bard is unable to determine the associated labeling to review. Although the product family is unknown, the nasogastric tube product ifus are found to be adequate based on past reviews. (b)(4). 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. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[94067513]
It was reported that the patient had an allergic reaction while using the nasogastric tube in (b)(6) 2016. The complainant reported that the episode was acute and required the use of epinephrine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2017-06269 |
| MDR Report Key | 7094876 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-12-07 |
| Date of Report | 2017-12-07 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-12-07 |
| 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 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASOGASTRIC SUMP TUBE DUAL LUMEN |
| Generic Name | NASOGASTRIC TUBE |
| Product Code | BSS |
| Date Received | 2017-12-07 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-07 |