MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-07-10 for BONE MARROW ASPIRATION NEEDLE 11 GAUGE + 13 GAUGE 74031 manufactured by Ranfac Corp.
[19491802]
It has been reported that 2 different gauge size needles were broken by a physician while they were being used in a patient during an aspiration procedure. The medical personnel decided after reviewing a ct scan to leave the broken tips in the pelvis of the pt because they were embedded and not believed to present a danger to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211566-2001-00001 |
| MDR Report Key | 341323 |
| Report Source | 05 |
| Date Received | 2001-07-10 |
| Date of Report | 2001-07-10 |
| Date of Event | 2001-06-08 |
| Date Mfgr Received | 2001-06-11 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2001-07-13 |
| 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 | GEORGE HATTUB |
| Manufacturer Street | 30 DOHERTY AVE |
| Manufacturer City | AVON MA 02322 |
| Manufacturer Country | US |
| Manufacturer Postal | 02322 |
| Manufacturer Phone | 5085884400 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE MARROW ASPIRATION NEEDLE |
| Generic Name | ASPIRATION NEEDLE |
| Product Code | LWE |
| Date Received | 2001-07-10 |
| Model Number | 11 GAUGE + 13 GAUGE |
| Catalog Number | 74031 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 330653 |
| Manufacturer | RANFAC CORP |
| Manufacturer Address | 30 DOHERTY AVE AVON MA 02322 US |
| Baseline Brand Name | BONE MARROW ASPIRATION NEEDLE |
| Baseline Generic Name | ASPIRATION NEEDLE |
| Baseline Model No | 11 GAUGE + 13 G |
| Baseline Catalog No | 74031 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-10 |