MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for BD MAGNI-GUIDE SCALE MAGNIFIER & NEEDLE GUIDE FOR INSULIN SYRINGES NDC/HRI NO. 08290-3282-33 328233 manufactured by Bd.
[92043427]
This concerns the bd magni-guide , a syringe guide and magnifier i purchased from (b)(6). The unit i received may just be defective, but i've emailed them 5 times and they've never responded. So i'm assuming it's made properly and it is endangering people's lives. I use this bd product with bd bottles of insulin. If i put the syringe in the magni-guide, the barrell flange hits the top of the magnifier and the needle does not get into the bottle far enough to get any insulin. I know this because i've twice pulled the plunger to get insulin and then emptied the syringe into my hand - empty both times. Then i realized they are selling this device to people with vision problems. The insulin is clear and they most likely can't see that there is nothing in the syringe and may think they are injecting the proper dosage of medicine. If they are not getting any insulin, their lives would be in danger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073320 |
| MDR Report Key | 7027729 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-10-09 |
| Date Added to Maude | 2017-11-14 |
| 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 | PATIENT |
| 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 | 3 |
| Brand Name | BD MAGNI-GUIDE SCALE MAGNIFIER & NEEDLE GUIDE FOR INSULIN SYRINGES |
| Generic Name | MAGNIFIER HAND-HELD, LOW VISION |
| Product Code | OSS |
| Date Received | 2017-11-13 |
| Model Number | NDC/HRI NO. 08290-3282-33 |
| Catalog Number | 328233 |
| Lot Number | 19637213 |
| ID Number | NDC/HRI NO. 08290-3282-33 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Brand Name | BD MAGNI-GUIDE SCALE MAGNIFIER & NEEDLE GUIDE FOR INSULIN SYRINGES |
| Generic Name | MAGNIFIER HAND-HELD, LOW VISION |
| Product Code | HJF |
| Date Received | 2017-11-13 |
| Model Number | NDC/HRI NO. 08290-3282-33 |
| Catalog Number | 328233 |
| Lot Number | 19637213 |
| ID Number | NDC/HRI NO. 08290-3282-33 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |