MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for B. BRAUN TUBING manufactured by B. Braun Medical Inc..
[140445024]
Primary rn was hanging chemo on pt and as soon as equashield luer locked, chemo stopped immediately. There was an equashield on tubing prior, but rn replaced a new one before hanging chemo. Therefore, the leak came after the new equashield was replaced. It was not considered a chemo spill because it was less than 5ml. Tubing was changed and a new equashield replaced before therapy started and there was no incident. Pt free from harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085305 |
| MDR Report Key | 8464387 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-03-10 |
| Date Added to Maude | 2019-03-29 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | B. BRAUN TUBING |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2019-03-28 |
| Lot Number | 0061656319 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Brand Name | EQUASHIELD LUER LOCK |
| Generic Name | CLOSED ANTICOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM |
| Product Code | ONB |
| Date Received | 2019-03-28 |
| Lot Number | 1820415 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | EQUASHIELD LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |