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 2020-03-31 for JP 1000ML EPUMP SET 973656 manufactured by Covidien.
[185813609]
A device history record review could not be reviewed since the lot number is unknown. One used sample was received for evaluation. During the functional evaluation there was no food clogging the line however the silicone tubing was clearly damaged causing it to leak onto the union between the mistic and silicone tubing. Root cause could be found related to manufacturing/production process. The probable root cause may occur during use of the product due to stretching of the silicone tubing causing the detachment. A formal investigation action is not being taken since the reported condition is a rare occurrence. This complaint will be closed with no further action and will be used for tracking and trending purposes to determine a need for corrective/preventative actions.
Patient Sequence No: 1, Text Type: N, H10
[185813610]
The customer reported that a leakage occurred from the pump set during priming.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2020-08990 |
| MDR Report Key | 9903390 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-24 |
| Date Mfgr Received | 2019-12-24 |
| Date Added to Maude | 2020-03-31 |
| 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 | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JP 1000ML EPUMP SET |
| Generic Name | PUMP, INFUSION, ENTERAL |
| Product Code | LZH |
| Date Received | 2020-03-31 |
| Model Number | 973656 |
| Catalog Number | 973656 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |