MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for HALYARD 44610 8160-20 manufactured by Avanos Medical, Inc..
[185711377]
From staff: percutaneous endoscopic gastrostomy (peg) tube placed. Patient started experiencing abdominal discomfort so a ct scan without contrast was performed which showed a degree of free air which was felt to be due to placement of the peg tube. A rapid response was called. Patient was given oxygen via bag mask and atropine 0. 5 mg iv x2 doses. A dopamine drip was quickly started. No pulse was palpable. Resuscitation efforts were discontinued. Patient was pronounced deceased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9902720 |
| MDR Report Key | 9902720 |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-28 |
| Report Date | 2020-03-20 |
| Date Reported to FDA | 2020-03-20 |
| Date Reported to Mfgr | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| 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 | 0 |
| 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 | HALYARD |
| Generic Name | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | KNT |
| Date Received | 2020-03-31 |
| Model Number | 44610 |
| Catalog Number | 8160-20 |
| Lot Number | 20016182 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVANOS MEDICAL, INC. |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-31 |