MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-31 for BONE MARROW ASPIRATION NEEDLE SET STYLET #412 manufactured by Popper & Sons, Inc..
[14455]
During bone marrow aspiration of the left iliac crest, approx 2 inch distal portion of needle broke off at hub of sheath. Broken portion remained in subcutaneous tissue of the pt. Pt in no distress-stable condition surgery consult needed to remove device. Needle removed in radiology special procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26372 |
| MDR Report Key | 26372 |
| Date Received | 1995-07-31 |
| Date of Report | 1995-03-13 |
| Date of Event | 1995-03-07 |
| Date Facility Aware | 1995-03-16 |
| Report Date | 1995-03-16 |
| Date Reported to FDA | 1995-03-16 |
| Date Reported to Mfgr | 1995-03-16 |
| Date Added to Maude | 1995-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE MARROW ASPIRATION NEEDLE SET |
| Generic Name | NEEDLE SET |
| Product Code | LWE |
| Date Received | 1995-07-31 |
| Catalog Number | STYLET #412 |
| Lot Number | NEEDLE 406 |
| ID Number | SIZE 16 GAUGE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 27046 |
| Manufacturer | POPPER & SONS, INC. |
| Manufacturer Address | 300 DENTON AVE. NEW HYDE PARK NY 110403437 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-31 |