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

Catalog Number 51449

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

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 Description

The customer did not provide any patient information or outcome.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event 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
• Type of Device: GDP-10, GRAFT DELIVERY PACK, 10:3
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: gary dark ; 10810 w. collins ave.; lakewood, CO 80215 ; 3035425102
• MDR Report Key: 9180581
• MDR Text Key: 177882438
• Report Number: 1722028-2019-00300
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 05020583514492
• UDI-Public: 05020583514492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 51449
• Device Lot Number: 10A9911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other