MAUDE Adverse Event Report: TERUMO BCT HARVEST AUTOLOGOUS THROMBIN KIT; HAT KIT

Catalog Number HATKIT

Device Problems Shelf Life Exceeded (1567); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2015

Event Type  malfunction  

Event Description

The customer reported that after opening a harvest autologous thrombin kit, it was noticed that the expiration date on the bottles inside was 12/2014.The outer carton of the kit was labelled with an expiration date of 06/2015.The customer had five other kits of this lot number in their inventory.The sets were not used and no adverse event occurred.Due to (b)(4) personal data protection laws, the patient information is not available from the customer.Terumo bct is awaiting return of the disposable kit for evaluation.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

No injury was reported for this event.

Manufacturer Narrative

Investigation: this kit was discontinued from sale in october 2014.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the disposable sets were unavailable for return for analysis.It is possible that the customer discarded the original outer packaging which contains the set expiry information.Root cause: a definitive root could not be determined.It is possible that the outer kit packaging was discarded, prior to use, which contained the correct kit expiry information, based on the shortest component expiration date.

Event Description

The disposable set is not available for return because the customer discarded it.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated.

• Brand Name: HARVEST AUTOLOGOUS THROMBIN KIT
• Type of Device: HAT KIT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4704430
• MDR Text Key: 5724608
• Report Number: 1722028-2015-00146
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: HATKIT
• Device Lot Number: 86330051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/12/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other