MAUDE Adverse Event Report: TERUMO BCT 51449 HARVEST TERUMO; GDP-10, GRAFT DELIVERY PACK, 10:3

Catalog Number	51449
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed to provide additional information.Investigation: a dhr search was not performed for this complaint record as the reported adverse event did not relate to activities associated with the manufacturing of this lot.All lots must meet acceptance criteria for release.Correction: terumo bct customer support contacted the distributor on (b)(6) 2019 to alert them of this error.Root cause: based on the clinical findings, the use of the expired set was caused by an operator error.
Event or Problem Description
The customer did not provide any patient information or outcome.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
Upon review of the information provided by the distributor, it was discovered that an expired gdp-10 graft delivery system disposable was used on a patient.The gdp-10 disposable was labeled with an expiration date of 09-01-2019 and the procedure was performed on (b)(6) 2019.The product was collected and processed then injected back to the patient.Patient information and outcome are not available at this time.The gdp-10 graft delivery system set is not available for return because it was discarded by the customer.

• Brand Name: 51449 HARVEST TERUMO
• Common Device Name: GDP-10, GRAFT DELIVERY PACK, 10:3
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9180581
• Report Number: 1722028-2019-00300
• Device Sequence Number: 2606426
• Product Code: FMF
• UDI-Device Identifier: 05020583514492
• UDI-Public: 05020583514492
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K043261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 51449
• Device Lot Number: 10A9911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other