MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for SYMPHONY 673405 manufactured by Medela Llc.
[177370412]
Condensation in tubing when pumping and low suction. Had to turn suction up high. Valve and stem fit very loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659282 |
| MDR Report Key | 9659282 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-11-22 |
| Report Date | 2019-12-30 |
| Date Reported to FDA | 2019-12-30 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SYMPHONY |
| Generic Name | BREAST PUMP KIT |
| Product Code | HGX |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2019-11-22 |
| Catalog Number | 673405 |
| Lot Number | 456130 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDELA LLC |
| Manufacturer Address | 1101 CORPORATE DR. MCHENRY IL 60050 US 60050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |