MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-23 for HARVEST TERUMO 51422 manufactured by Terumo Bct.
[103546746]
Additional product code: fmf investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[103546747]
Upon review of information provided by the distributor, it was discovered that an expiredbone marrow aspirate concentrate (bmac) disposable set was used for surgery that was performed on (b)(6) 2018. The product was collected with the bmac disposable set then injected back to the patient. The bmac product set expired on 02/01/2018. Patient weight is not available at this time. Patient outcome is not available at this time. The bmac set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00073 |
| MDR Report Key | 7365509 |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-10-26 |
| Device Manufacturer Date | 2017-05-09 |
| Date Added to Maude | 2018-03-23 |
| 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 | STEVE KERN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARVEST TERUMO |
| Generic Name | BMAC2 60-01, BONE MARROW ASPIRATE CONCENTRATE PROCEDUR |
| Product Code | JQC |
| Date Received | 2018-03-23 |
| Catalog Number | 51422 |
| Lot Number | 05A9915 |
| Device Expiration Date | 2018-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80217 US 80217 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-23 |