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 2020-03-10 for J001FO 1000ML JOEY FEED BAG TYPE X30 manufactured by Covidien.
[183170257]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[183170258]
The customer reported that the device was opened and attached to the pump. The nutrition was started and an hour and a half later the dosing completion alarm sounded. Upon checking, it was found that a nutrient solution was leaking under the pump. Leaking from the silicone tube had been suspected. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040459-2020-00516 |
| MDR Report Key | 9810953 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-10 |
| 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 | 117 MOO 2, PETCHKASEM RD, SAMP |
| Manufacturer City | NAKORN PATHOM 73110 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 73110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J001FO 1000ML JOEY FEED BAG TYPE X30 |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-10 |
| Model Number | J001FO |
| Catalog Number | J001FO |
| Lot Number | 1924801FJY |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 117 MOO 2, PETCHKASEM RD, SAMP NAKORN PATHOM 73110 TH 73110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |