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

Catalog Number 000000000000080300

Device Problems Improper or Incorrect Procedure or Method (2017); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

The customer reported a needle stick injury that occurred when removing the needle to re-stick the patient before beginning a whole blood donation.Per the customer, the operator failed to engage the needle guard properly during needle removal.A post-exposure diagnostic test was given; results are not available.The patient (operator) is reported in healthy condition.Donor unit #: (b)(6).The customer declined to provide patient's (operator) identifier and weight.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to device malfunction that has the potential for death or injury if the same failure were to recur.

Manufacturer Narrative

Investigation: the customer stated that is a training issue.Terumo bct will follow-up with the customer.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: 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.Per the trima accel manual, the masterguard needle protector engages into a locked position only if it is held in place while the apheresis needle is removed by pulling the tubing.It does not engage if the wings of the needle or body of the needle protector are used to remove the needle.After use, visually confirm that the needle protector is locked over the needle and that the wings are securely held behind the locking prongs.Root cause: this disposable was unavailable for specific root cause analysis.Per feedback from the customer¿s director of donor services, this incident is most likely due to an operator training issue.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA ACCEL PLATELET, PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4005437
• MDR Text Key: 4689327
• Report Number: 1722028-2014-00306
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK970005
• 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
• Report Date: 07/16/2014

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: 000000000000080300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 08/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR