MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-04-07 for 30328 13GAX2IN BN NARROW SNARECOIL NDL SC2013X * manufactured by Ranfac.
[378017]
A customer had a problem with the bn marrow snarecoil ndl. The customer states "needle snapped in half and plastic hub separated from needle causing needle portion to remain in patient. Doctor was able to remove a piece but has to schedule surgery to remove remaining piece. Injection was on the right posterial ilica bone. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2005-00005 |
| MDR Report Key | 589884 |
| Report Source | 05,07 |
| Date Received | 2005-04-07 |
| Date of Report | 2005-04-06 |
| Report Date | 2005-04-06 |
| Date Reported to FDA | 2005-04-06 |
| Date Reported to Mfgr | 2005-04-06 |
| Date Added to Maude | 2005-04-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADRIENNE MARCELLUS, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO/KENDALL HEALTHCARE |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 30328 13GAX2IN BN NARROW SNARECOIL NDL |
| Generic Name | BONE MARROW NEEDLE |
| Product Code | LWE |
| Date Received | 2005-04-07 |
| Model Number | SC2013X |
| Catalog Number | * |
| Lot Number | 10017 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 579733 |
| Manufacturer | RANFAC |
| Manufacturer Address | 30 DOPHERTY AVE AVON MA * US |
| Baseline Brand Name | 13GAX2IN BN MARROW SNARECOIL NDL |
| Baseline Generic Name | BONE MARROW BOPSY NEELE |
| Baseline Model No | * |
| Baseline Catalog No | SC2013X |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-07 |