MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET

Catalog Number 80440

Device Problems Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported a needle stick injury that occurred after a collection procedure.Per the customer, the needle stick occured on the operator with a contaminated needle due to the needle not retracting properly into the needle protector.It is unknown at this time if medical intervention was required for this event.Donor unit #: (b)(6).Patient (operator) information is not available at this time.The trima collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- improper technique in retracting the needle into the needle guard.- defective needle guard.

Event Description

The customer declined to provide patient (operator) outcome.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is in-process.A follow-up report will be provided.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL ENHANCED PLATELET, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7121469
• MDR Text Key: 95524751
• Report Number: 1722028-2017-00485
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2017

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 Expiration Date: 07/01/2019
• Device Catalogue Number: 80440
• Device Lot Number: 1707282130
• Other Device ID Number: 05020583804401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/15/2017; 03/24/2018
• Supplement Dates FDA Received: 01/09/2018; 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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
• Patient Age: 00047 YR
• Patient Weight: 85