MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-08-31 for JAMSHIDI BONE MARROW BIOPSY/ASPIRATYLON TRAY BAK4511 manufactured by Allegiance Healthcare Corporation.
[227557]
Biopsy sample was stuck inside after needle was bent. The physician was injured with needle (sustained needle stick) while attempting to retrieve the bone marrow biopsy sample. Most likely lot number is l1e024.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2001-00225 |
| MDR Report Key | 349514 |
| Report Source | 05,06 |
| Date Received | 2001-08-31 |
| Date of Report | 2001-08-31 |
| Date of Event | 2001-07-25 |
| Date Mfgr Received | 2001-08-03 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2001-09-04 |
| 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 | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAMSHIDI BONE MARROW BIOPSY/ASPIRATYLON TRAY |
| Generic Name | BONE MARROW BIOPSY TRAY |
| Product Code | LWE |
| Date Received | 2001-08-31 |
| Model Number | BAK4511 |
| Catalog Number | BAK4511 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 338814 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORPORATION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | JAMSHIDI BONE MARROW BIOPSY/ASPIRATION TRAY |
| Baseline Generic Name | BONE MARROW BIOSPY TRAY |
| Baseline Model No | BAK4511 |
| Baseline Catalog No | BAK4511 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-08-31 |