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 BUG) ADULT MODEL WMBIG A1 NA manufactured by Waismed Ltd..
[16751353]
Customer reported to distributor on initial report that device did not fire the retracted needle properly. Learned from distributor calls to customer that the big was attempted to be used to gain io access in an emergency pt and the device did not fire properly. No other details were given to understand the exact meaning of this statement. Device was placed onto the site of the pt and paramedic tried to activate it. They did not see the needle exit the device. The customer did not keep the device or its packaging to return for investigation.
Patient Sequence No: 1, Text Type: D, B5
[17085348]
We made multiple calls to customer to try and understand how device did not fire properly. We did not obtain the device and the customer just explanted that it did not fire. We tried to take customer through the steps of using the device to see if this could help us understand the stage when it did not fire. Without the device and not knowing if latch was removed to allow needle to fire, we cannot clearly address the problem. We did replaced product and offer re-training. We asked about handling procedures and was not able to learn more from customer to understand if handling was a reason. We did checked our qc processes and the lot number from this complaint and could not repeat the complaint. We receive report of the incident from united states distributor (b)(4) 2007. They did not receive the report from end under on (b)(4) 2007, but on (b)(4) 2007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616791-2007-00002 |
| MDR Report Key | 2783834 |
| Report Source | 06,08 |
| Date Received | 2007-05-29 |
| Date of Report | 2007-05-12 |
| Date of Event | 2007-03-09 |
| Date Mfgr Received | 2007-04-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 BUG) ADULT MODEL |
| Generic Name | INTRAOSSEOUS DEVICE |
| Product Code | MHC |
| Date Received | 2007-05-29 |
| Model Number | WMBIG A1 |
| Catalog Number | NA |
| Lot Number | 131 |
| 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 |