MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for HARVEST TERUMO 51400 manufactured by Terumo Bct.
[145981903]
Investigation: a terumo bct sales representative initially contacted a customer from (b)(6) as a prospective account. Per the customer, the smp2 had not been used "in a longtime". The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident. All lots must meet acceptance criteria before release. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[145981904]
The customer reported that a pc-30 harvest set that had been expired for approximately 12 years was used while attempting to isolate some growth factors. The support specialist reach out to the customer and instructed them to stop using the product. During subsequent follow-up with the customer, the customer confirmed that they had disposed of the product, the patient was doing 'fine' and they are pleased with the patient's outcome. The customer declined to provide the patient information. The pc-30 harvest set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2019-00068 |
| MDR Report Key | 8464067 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-29 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-03-29 |
| 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 | DENTIST |
| 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 | PC-30 PLATELET CONC PROCEDURE SET |
| Product Code | ORG |
| Date Received | 2019-03-29 |
| Catalog Number | 51400 |
| 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 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-29 |