MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2007-05-29 for BIG (BONE INJECTION GUN) PEDIATRIC DEVICE WMBIG C2 NA manufactured by Waismed Ltd..
[2913002]
Customer reported that device did not fire correctly out of device. Additional calls to customer could not ascertain more details other than device didn't fire properly. We did not get the device back (it was discarded along with packaging) and we were not informed until (b)(6) 2007 from customer and distributor.
Patient Sequence No: 1, Text Type: D, B5
[10209380]
Report from customer was vague on all attempted phone calls. We could not understand what was the definition of not firing properly. Device has safety latch that needs to be removed in order for needle to fire. Customer states they were using it correctly. We did not get notified of the event until (b)(6) 2007. We investigated our manufacturing process, checked various lots to see if any were not functioning properly. We performed drop tests differently than previously to try and cause the needle to dislodge from internal holder - and could not recreate a misfire, drop test of the devices in their box could not recreate a loose needle. We are checking on possible packaging changes to strengthen holding the device inside the package making assumptions that paramedics handle devices with extreme roughness. We offered free replacement of customer's inventory with newer stock and offer was not accepted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616791-2007-00003 |
| MDR Report Key | 2783842 |
| Report Source | 06,08 |
| Date Received | 2007-05-29 |
| Date of Report | 2007-05-14 |
| Date of Event | 2007-01-25 |
| Date Added to Maude | 2012-10-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | HANATRAN 3 |
| Manufacturer City | KIRYAT-GAT 82000 |
| Manufacturer Country | IS |
| Manufacturer Postal | 82000 |
| Manufacturer Phone | 9729955021 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIG (BONE INJECTION GUN) PEDIATRIC DEVICE |
| Generic Name | INTRAOSSEOUS DEVICE |
| Product Code | MHC |
| Date Received | 2007-05-29 |
| Model Number | WMBIG C2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAISMED LTD. |
| Manufacturer Address | HERTZLIYA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-29 |