MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-04-23 for 30328 13GX3 IN BN MARR SC NEEDLE * SC3513X manufactured by Outside Vendor-ranfac Corp..
[16267595]
It was reported to tycohealthcare kendall in 2004 that the physician using the needle was unable to remove the specimen from the needle shaft. He followed the manufactures guide lines for using the needle but he could not remove the specimen. The pt had to be stuck twice for the biopsy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2004-00009 |
| MDR Report Key | 551473 |
| Report Source | 05,07 |
| Date Received | 2004-04-23 |
| Date of Report | 2004-03-23 |
| Date Facility Aware | 2004-03-23 |
| Report Date | 2004-04-22 |
| Date Mfgr Received | 2004-03-23 |
| Date Added to Maude | 2004-10-27 |
| 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 | MARTHA PORTNOW, RN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618547 |
| Manufacturer G1 | OUTSIDE VENDOR RANFAC CORP. |
| Manufacturer Street | 30 DOHERTY AVE |
| Manufacturer City | AVON MA 02322 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02322 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 30328 13GX3 IN BN MARR SC NEEDLE |
| Generic Name | BONE MARROW BIOPSY NEEDLE |
| Product Code | LWE |
| Date Received | 2004-04-23 |
| Model Number | * |
| Catalog Number | SC3513X |
| Lot Number | 10887 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 540990 |
| Manufacturer | OUTSIDE VENDOR-RANFAC CORP. |
| Manufacturer Address | 30 DOHERTY AVENUE AVON MA 02322 US |
| Baseline Brand Name | 30328 13GX3 IN BN MARR SC NEEDLE |
| Baseline Generic Name | BONE MARROW BIOPSY NEEDLE |
| Baseline Model No | * |
| Baseline Catalog No | SC3513X |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-04-23 |