MAUDE Adverse Event Report: TERUMO BCT HARVEST TERUMO; BAN-25 8GA BM ASPIRATE NEEDLE

Catalog Number	51448
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) lot number, expiry date and manufacture date are not available at this time.Investigation: the technician at the customer site provided photographs of both the inner and outer packaging to terumo bct.The lot number on the ban-25-0016 outer box had an expiration date of 01-aug-2018.The inner, primary packaging of the needle had a different expiration date of 01-nov-2018.The procedure was performed on (b)(6) 2018.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that an expired bone marrow aspirate concentrate (bmac) disposable was used on a patient.The bmac disposable was labeled with an expiration date of (b)(6) 2018.The procedure was performed on (b)(6) 2018.No adverse events reported for this event.The customer declined to provide patient information.The ban-25 8ga bm aspirate needle is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information.Investigation: per follow up, it was found that lot ban25-0016 was manufactured with two different vendor lots, having expiry of 01-aug-2018 on one lot and expiry of 01-nov-2018 on another lot.And since the kits are limited by the shortest shelf life, the overall expiration date for ban25-0016 is 01-aug-2018.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.The harvest disposable set was unavailable for return and investigation.Harvest product kits contain multiple components that have various expiration dates.The outer kit label contains the expiration date associated with the component that has the shortest expiry timeframe.Correction: terumo bct customer support contacted the customer to discuss the importance of checking the expiration date on the set prior to the procedure and to retrain to avoid further use of expired kits.The customer declined the requirement for additional training.Root cause: based on the clinical findings, the use of the expired set was caused by an operator error.

• Brand Name: HARVEST TERUMO
• Common Device Name: BAN-25 8GA BM ASPIRATE NEEDLE
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8166329
• Report Number: 1722028-2018-00341
• Device Sequence Number: 16679871
• Product Code: FMF
• UDI-Device Identifier: 05020583514485
• UDI-Public: 05020583514485
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2018

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 Catalogue Number: 51448
• 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: 11/21/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/07/2019
• 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