MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-01 for 18FR SALEM W/ GIENTRI PORT WIT 7771810E manufactured by Covidien.
[143825234]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[143825235]
The customer reports the patient's salem sump tube was hooked to the wall suction, set to low intermittent suction. The output was low; however, there's bilious output in the tubing and after 3 hours the patient had a bilious emesis, zofran was administered right away. The nursing staff started trouble shooting and checked the wall suction which was functioning properly. The nurses checked the tube and adapter and found it was flushing fine and the arrow and setting was where it was supposed to be. A new adapter was tried with no improvement. An x-ray confirmed that the tube was in the correct place. The patient wasn't in distress; she was comfortable after the emesis episode. However, hours later, when the nurses stood the patient up at bedside, she had her 2nd episode of bile emesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2019-02163 |
| MDR Report Key | 8569784 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-01 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD IND |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 18FR SALEM W/ GIENTRI PORT WIT |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2019-05-01 |
| Model Number | 7771810E |
| Catalog Number | 7771810E |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |