MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for ILLINOIS (TJ) NEEDLE ASPIRATION 15GA TIN3015 manufactured by Carefusion, Inc.
[130168250]
(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[130168251]
Just had another bone marrow needle without the safety cover on today, and unfortunately, it resulted in a needle stick to the staff member. This was not part of a larger kit. It was a single needle pack that the nurse was pulling out of a storage bin. It looks like the needle also punctured the needle package that was next to it in the bin, so we can no longer consider that needle sterile. On (b)(6) 2018 customer response: it was not recorded or specified that a medical intervention took place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2018-00061 |
| MDR Report Key | 8155569 |
| Date Received | 2018-12-12 |
| Date of Report | 2019-01-21 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILLINOIS (TJ) NEEDLE ASPIRATION 15GA |
| Generic Name | BONE MARROW COLLECTION/TRANSFUSION KIT |
| Product Code | LWE |
| Date Received | 2018-12-12 |
| Catalog Number | TIN3015 |
| Lot Number | 1200458 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-12 |