MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-02-08 for ILLINOIS (TJ) NEEDLE ASPIRATION 15GA TIN3015 manufactured by Carefusion, Inc.
[135859821]
(b)(6) 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
[135859822]
Per report, a nurse sustained a puncture injury to unidentified hand while reaching in the bin during attempt to get the custom procedure pack with exposed aspiration needle (protective cover was off). The employee did not go the emergency department or undergo any exposure testing since the needle is a sterile one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00006 |
| MDR Report Key | 8322881 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-27 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-08 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLINOIS (TJ) NEEDLE ASPIRATION 15GA |
| Generic Name | BONE MARROW COLLECTION/TRANSFUSION KIT |
| Product Code | LWE |
| Date Received | 2019-02-08 |
| Catalog Number | TIN3015 |
| Lot Number | 0001230001 |
| 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 | 2019-02-08 |