MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-12-05 for J NEEDLE 8G X 4" 7834 manufactured by Popper Precision Instruments.
[18478951]
Cannula separated from handle assy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213649-2001-00001 |
| MDR Report Key | 366514 |
| Report Source | 08 |
| Date Received | 2001-12-05 |
| Date of Report | 2001-12-05 |
| Date of Event | 2001-11-06 |
| Date Facility Aware | 2001-11-06 |
| Report Date | 2001-12-05 |
| Date Reported to FDA | 2001-12-05 |
| Date Reported to Mfgr | 2001-11-30 |
| Date Mfgr Received | 2001-11-30 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2001-12-20 |
| 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 | 3 |
| Manufacturer Street | 267 JENCKES HILL ROAD |
| Manufacturer City | LINCOLN RI 02865 |
| Manufacturer Country | US |
| Manufacturer Postal | 02865 |
| Manufacturer Phone | 4013343600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J NEEDLE 8G X 4" |
| Generic Name | REUSABLE BONE MARROW BIOPSY NEEDLE |
| Product Code | GDM |
| Date Received | 2001-12-05 |
| Returned To Mfg | 2001-11-29 |
| Model Number | NA |
| Catalog Number | 7834 |
| Lot Number | 1B 5974I |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 355637 |
| Manufacturer | POPPER PRECISION INSTRUMENTS |
| Manufacturer Address | 267 JENCKES HILL ROAD LINCOLN RI 02865 US |
| Baseline Brand Name | J NEEDLE |
| Baseline Generic Name | J-JAMSHIDEI TYPE BONE MARROW BIOPSY NEEDLE |
| Baseline Model No | NA |
| Baseline Catalog No | 7834 |
| Baseline ID | 8G X 4" |
| Baseline Device Family | BONE MARROW BIOPSY ASPIRATION NEEDLE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K843830 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-12-05 |