MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-13 for 777405 EPUMP ENPLUS SPIKE AND 1LT FLUSH manufactured by Covidien.
[184631168]
An investigation is currently underway.? Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[184631169]
The customer reported that when providing medication through the medication port, the feeding sets were leaking from the mistic connector area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611018-2020-00418 |
| MDR Report Key | 9828914 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-13 |
| 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 | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | SRAGH INDUSTRIAL ESTATE, CO, T |
| Manufacturer City | OFFALY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 777405 EPUMP ENPLUS SPIKE AND 1LT FLUSH |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-13 |
| Model Number | 777405 |
| Catalog Number | 777405 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | SRAGH INDUSTRIAL ESTATE, CO, T OFFALY EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |