MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for BVI VISITEC 585738 manufactured by Beaver-visitec International.
[113025056]
Bvi visitec anterior chamber cannula (rycroft). 30 x 22 mm used on luer lock syringe. This is the 3rd case where the cannula "pops" off the syringe while in use. Case #1 - no damage to eye. Case #2 - damage to eye as the cannula "popped" off during use while injecting in eye. Case #3 - minor damage/bleeding due to same issue. Cannula popped off during injection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078183 |
| MDR Report Key | 7654473 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-27 |
| Date Added to Maude | 2018-07-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BVI VISITEC |
| Generic Name | ANTERIOR CHAMBER CANNULA |
| Product Code | HMX |
| Date Received | 2018-06-29 |
| Model Number | 585738 |
| Lot Number | 3210654 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAVER-VISITEC INTERNATIONAL |
| Manufacturer Address | WALTHAM MA 02452 US 02452 |
| Brand Name | BVI VISITEC |
| Generic Name | ANTERIOR CHAMBER CANNULA |
| Product Code | HMX |
| Date Received | 2018-06-29 |
| Model Number | 585738 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BEAVER-VISITEC INTERNATIONAL |
| Manufacturer Address | WALTHAM MA 02452 US 02452 |
| Brand Name | BVI VISITEC |
| Generic Name | ANTERIOR CHAMBER CANNULA |
| Product Code | HMX |
| Date Received | 2018-06-29 |
| Model Number | 585738 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BEAVER-VISITEC INTERNATIONAL |
| Manufacturer Address | WALTHAM MA 02452 US 02452 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-06-29 |