MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for UKNOWN NASOGASTRIC TUBE UNKNOWN manufactured by C.r. Bard, Inc. (covington) -1018233.
[127533589]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[127533590]
It was reported that the nasogastric tube broke during a laparoscopic gastric bypass. The patient experienced an unspecified injury. Per additional information from complainant via email on (b)(6) 2018, the anesthesiologist (complainant) was involved in a laparoscopic gastric bypass in (b)(6) 2008. The complainant stated the following,"the surgeon used orogastric tubes rather than bougies to aid in creation of the neo stomach. Inadvertently, the og tube was stapled into the field, and no notification provided to myself or the surgical team. The case proceeded, the og tube was removed, and the patient was awakened and recovered and discharged the next day. She complained of intermittent stomach discomfort and occasional nausea over the next 8 years, until a different surgeon ordered a ct scan of the abdomen, which revealed a remnant of the og tube still in place. She underwent laparoscopic removal of the og tube remnant in 2016". The complainant referred to a unknown bard ng 18french tube. The device was transected by a surgical stapling device. The break of the device was identified in (b)(6) 2016 via ct scan. Og tube fragments were removed by a 2nd laparoscopic procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-05475 |
| MDR Report Key | 8081974 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-30 |
| Date Mfgr Received | 2018-11-28 |
| Date Added to Maude | 2018-11-16 |
| 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 | YONIC ANDERSON |
| 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 | 0 |
| Brand Name | UKNOWN NASOGASTRIC TUBE |
| Generic Name | NG TUBE |
| Product Code | BSS |
| Date Received | 2018-11-16 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2018-11-16 |