MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-20 for ILLINOIS NEEDLE BONE MARROW BIOPSY DIN1515X manufactured by Carefusion, Inc.
[96020564]
Pr (b)(4). A follow up submission will be done upon completion of carefusion's investigation or additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[96020565]
During inspection, bd (b)(4) confirmed that 122 products out of 2740 weren't sealed properly therefore compromising sterility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680904-2017-00231 |
| MDR Report Key | 7134994 |
| Date Received | 2017-12-20 |
| Date of Report | 2018-02-08 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2017-05-05 |
| Date Added to Maude | 2017-12-20 |
| 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 | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | ZONA FRANCA LAS AMERICAS |
| Manufacturer City | SANTO DOMINGO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILLINOIS NEEDLE BONE MARROW BIOPSY |
| Generic Name | BONE MARROW BIOPSY |
| Product Code | FSH |
| Date Received | 2017-12-20 |
| Catalog Number | DIN1515X |
| Lot Number | 1097560 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-20 |