MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-07-25 for JAMSHIDI BONE MARROW BIOPSY NEEDLE DJ4011X manufactured by Allegiance Healthcare Corp..
[166530]
Needle snapped in half while being used in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2000-00187 |
| MDR Report Key | 287179 |
| Report Source | 07 |
| Date Received | 2000-07-25 |
| Date of Report | 2000-07-24 |
| Date of Event | 2000-06-14 |
| Date Mfgr Received | 2000-06-26 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2000-07-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475783636 |
| 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 NEEDLE |
| Generic Name | BONE MARROW BIOPSY NDL |
| Product Code | LWE |
| Date Received | 2000-07-25 |
| Model Number | DJ4011X |
| Catalog Number | DJ4011X |
| Lot Number | L9F058 |
| 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 | 277892 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | NEEDLE, 11GA X 4" JAMSHIDI BONE BIOPSY |
| Baseline Generic Name | NEEDLE |
| Baseline Model No | DJ4011X |
| Baseline Catalog No | DJ4011X |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-25 |