MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-08 for MAVIDON COLLODION REMOVER 128 OZ manufactured by Mavidon.
[22252311]
Collodion remover (mavidon) was used to remove eeg from this infant who was ecmo after open heart surgery. Shortly thereafter the pt bled from the right internal jugular central line. The baxter one-link needle free connector was found to be split, cloudy, mis-shapen and leaking. The cap was replaced and the bleeding stopped. Another connector was exposed to be collodion remover in-vitro and reacted the same way. Reason for use: to remove eeg leads.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042679 |
| MDR Report Key | 4771536 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-05-08 |
| Date of Event | 2015-04-30 |
| Date Added to Maude | 2015-05-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIDON COLLODION REMOVER 128 OZ |
| Generic Name | MAVIDON COLLODION REMOVER 128 OZ |
| Product Code | GYB |
| Date Received | 2015-05-08 |
| ID Number | UNIQUE ID # MD0013G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIDON |
| Brand Name | ONE-LINK NEEDLE-FREE IV CONNECTOR |
| Generic Name | ONE-LINK NEEDLE-FREE IV CONNECTOR |
| Product Code | FPA |
| Date Received | 2015-05-08 |
| Model Number | 7N8399 |
| Lot Number | 07-36-71-510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BAXTER |
| Manufacturer Address | DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-08 |