MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-11 for TRU GUIDE manufactured by C.r. Bard, Inc..
[18621]
A bone biopsy was being performed using the coaxial needle. The guide needle was removed and a 22 gauge westcott needle was introduced thru the sheath to obtain the specimen. The needle was removed. Then an attempt was made to remove the sheath but it snapped apart. The sheath could not be removed by forceps so the pt was taken to surgery for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32899 |
| MDR Report Key | 32899 |
| Date Received | 1996-03-11 |
| Date of Report | 1996-03-01 |
| Date of Event | 1996-02-28 |
| Date Added to Maude | 1996-05-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRU GUIDE |
| Generic Name | COAXIAL NEEDLE NAD DEPTH STOP |
| Product Code | MJG |
| Date Received | 1996-03-11 |
| Lot Number | 03BFS073 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34198 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | COVINGTON GA 30209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-03-11 |