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

Catalog Number 000000000000080440

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/30/2014

Event Type  malfunction  

Event Description

The customer reported a needle stick injury that occurred during an apheresis procedure.Per the customer, during rinseback, the operator failed to engage the needle guard properly.Per the customer, the donor was not injured.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: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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, SAMPLER, PLASMA, RBC SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4005501
• MDR Text Key: 4689820
• Report Number: 1722028-2014-00307
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK120049
• 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 Expiration Date: 02/01/2016
• Device Catalogue Number: 000000000000080440
• Device Lot Number: 02W1128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2014
• 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
• Date Device Manufactured: 03/01/2014
• 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: 33 YR