MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-12 for FILTER, INFUSION LINE AMS-426-1 manufactured by Vygon Usa.
[139114231]
There were three occurrences within this complaint. Those occurrences were captured in the following mdrs: 2245270-2019-00007, 2245270-2019-00008. Although the device was not returned to vygon, the details of the complaint will be examined as part of the complaint investigation. This investigation is currently in process and the results will be forwarded to fda within 30 days of its conclusion via follow-up mdr.
Patient Sequence No: 1, Text Type: N, H10
[139114232]
(b)(6) called to report an incident regarding significant leak (puddle on floor by patient) from extension set near connection with pump. Leak involved hazardous chemo drug. Due to extent of contamination, all components, fluids, etc. Were disposed of as hazardous waste. No leakage noted until after patient was switched to ns flush bag. Pump did not beep or alarm. Pembrolizumab infused for 24 minutes and ns infused for 10ml.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2019-00006 |
| MDR Report Key | 8414033 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-12 |
| Date of Report | 2019-01-25 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Date Added to Maude | 2019-03-12 |
| 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 | FREDA LACROIX |
| Manufacturer Street | 2750 MORRIS ROAD |
| Manufacturer City | LANSDALE PA 19446 |
| Manufacturer Country | US |
| Manufacturer Postal | 19446 |
| Manufacturer Phone | 8004735414 |
| Manufacturer G1 | VYGON MFG |
| Manufacturer Street | 87 VENTURE DRIVE |
| Manufacturer City | DOVER NH 03820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILTER, INFUSION LINE |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2019-03-12 |
| Model Number | AMS-426-1 |
| Lot Number | 1807049D |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON USA |
| Manufacturer Address | 2750 MORRIS ROAD LANSDALE PA 19446 US 19446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |