MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-05 for ADDEASE 13MM BINARY CONNECTOR N7993 manufactured by B. Braun Medical Inc.
[625104]
Addease 13mm activated prior to shipping. Product was stored at room temperature. Product also activated in patient's home within 24hrs of delivery. Drug doses had to be wasted. Patient also had problems with activation. When diluent was squeezed it would not release fluid into vial for 6 doses. Patient missed doses of antimicrobial therapy with current diagnosis of mrsa. Therapy had to be changed due to multiple issues with addease.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002543 |
| MDR Report Key | 863995 |
| Date Received | 2007-06-05 |
| Date of Report | 2007-06-05 |
| Date of Event | 2007-05-29 |
| Date Added to Maude | 2009-03-23 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | ADDEASE 13MM BINARY CONNECTOR |
| Generic Name | BINARY CONNECTOR |
| Product Code | GCD |
| Date Received | 2007-06-05 |
| Catalog Number | N7993 |
| Lot Number | J6H112 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC |
| Manufacturer Address | IRVINE CA 92614589 US 92614 5895 |
| Brand Name | ADDEASE 13MM BINARY CONNECTOR |
| Generic Name | BINARY CONNECTOR |
| Product Code | FPA |
| Date Received | 2007-06-05 |
| Catalog Number | N7993 |
| Lot Number | J6H113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC |
| Manufacturer Address | IRVINE CA 92614589 US 92614 5895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-05 |