MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-12-21 for L25 21 GAUGE NEEDLE GUIDE/COVER KIT P04053-01 manufactured by Sonosite,inc..
[415959]
Sonosite, inc. Received info from a customer that a 21 gauge needle would not permit the passage of a standard 21 gauge needle. When the needle guide is attached to the needle guide bracket on the l25 transducer, it is intended to facilitate placement of the needle into the scanning plane. In this situation, the clinician was not able to insert the needle through the guide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032367-2005-00001 |
| MDR Report Key | 657594 |
| Report Source | 08 |
| Date Received | 2005-12-21 |
| Date of Report | 2005-12-20 |
| Date of Event | 2005-11-22 |
| Date Mfgr Received | 2005-11-22 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-01-03 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 21919 30TH DRIVE SE |
| Manufacturer City | BOTHELL WA 980213904 |
| Manufacturer Country | US |
| Manufacturer Postal | 980213904 |
| Manufacturer Phone | 4259511200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | L25 21 GAUGE NEEDLE GUIDE/COVER KIT |
| Generic Name | DISPOSABLE NEEDLE GUIDE |
| Product Code | MIJ |
| Date Received | 2005-12-21 |
| Model Number | NA |
| Catalog Number | P04053-01 |
| Lot Number | VARIOUS |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 647067 |
| Manufacturer | SONOSITE,INC. |
| Manufacturer Address | * BOTHELL WA * US |
| Baseline Brand Name | L25 21 GAUGE NEEDLE GUIDE/COVER KIT |
| Baseline Generic Name | DISPOSABLE NEEDLE GUIDE |
| Baseline Model No | NA |
| Baseline Catalog No | P04053-01 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-21 |