MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-02-10 for BASIC BIOPSY TRAY 4380 manufactured by Allegiance Healthcare Corp..
[146605]
On january 12, 2000, while performing a biopsy lidocaine vial broke (shattered) while opening it, resulted in thumb laceration necessitating stitches. A second vial shattered in same fashion during biopsy immediately following the first biopsy. "this has never happened to me in my 14 years in medicine". Doctor also drew a picture of the vial and it was top part of the vial that shattered above the neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2000-00039 |
| MDR Report Key | 261698 |
| Report Source | 05,06 |
| Date Received | 2000-02-10 |
| Date of Report | 2000-02-10 |
| Date of Event | 2000-01-12 |
| Date Mfgr Received | 2000-01-19 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2000-02-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| Manufacturer G1 | SPECIAL PROCEDURE |
| Manufacturer Street | 400 EAST FOSTER ROAD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASIC BIOPSY TRAY |
| Generic Name | PROCEDURE TRAY |
| Product Code | FCH |
| Date Received | 2000-02-10 |
| Model Number | 4380 |
| Catalog Number | 4380 |
| Lot Number | L9H093 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 253449 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | BASIC BIOPSY TRAY |
| Baseline Generic Name | PROCEDURE TRAY |
| Baseline Model No | 4380 |
| Baseline Catalog No | 4380 |
| Baseline ID | NA |
| Baseline Device Family | PROCEDURE TRAY |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K813338 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-10 |