MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA LRS PLT W/FILTER+SAMPLER+AUTO

Catalog Number 4823832

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation: one used needle protector was received for investigation.Initial observations notes it was open and not closed shut.Two drops on blood were observed on the inside of the protector.The protector was inspected for any damage and none was noted.It was closed shut with no issues and it closed tightly.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the needle protector separated during needle removal from the donor, resulting in accidental blood exposure to the operator.The accidental exposure to blood procedure was applied, including serological testing and informing the hse service (health safety environment).The patient identifier and outcome are not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: one used needle protector was received for investigation.Initial observations notes it was open and not closed shut.Two drops on blood were observed on the inside of the protector.The protector was inspected for any damage and none was noted.It was closed shut with no issues and it closed tightly.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that the needle protector separated during needle removal from the donor, resulting in accidental blood exposure to the operator.The accidental exposure to blood procedure was applied, including serological testing and informing the hse service (health safety environment).The patient identifier and outcome are not available at this time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The customer reported that the needle protector separated during needle removal from the donor, resulting in accidental blood exposure to the operator.The accidental exposure to blood procedure was applied, including serological testing and informing the hse service (health safety environment).Pursuant to eu personal data protection laws, the patient identifier is not available from the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: one used needle protector was received for investigation.Initial observations notes it was open and not closed shut.Two drops on blood were observed on the inside of the protector.The protector was inspected for any damage and none was noted.It was closed shut with no issues and it closed tightly.Based on an internal medical safety review, this adverse event was caused by a trima disposable manufacturing error resulting in a device failure/malfunction.There was no suggested, mislabeling, improper or inadequate design, nor were there any reported user errors that contributed to or caused this adverse event.Current donor screening and testing practices lower the likelihood of a donor transmitting a viral infection to the operator via needle stick.According to transfusion-transmissible infections monitoring system (ttims) data hcv, hbv, and hiv positive prevalence per 100,000 from 2015 to 2019 was 19.0, 6.3, and 2.6 respectively.[ steele et al.2020] the rate of seroconversion or infection resulting from a needle stick injury is even lower, 6-30% for hbv, 0.3% for hiv, and 0.2% for hcv.[fenster & decker 2022] the rate of seroconversion of hbv is likely much lower due to high vaccination rates among healthcare workers.In the case of unvaccinated healthcare workers immediate initiation of post exposure prophylaxis is 70 to 75% effective in preventing infection.[schillie et al.2013] a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Correction: the relevant manufacturing personnel were made aware of this issue to mitigate recurrence.Root cause: the cause of this defect was related to a mis-assembly, where the assembler neglected to follow the appropriate manufacturing operating procedure of the disposable set during manufacturing.More specifically, the operator failed to adequately fasten the needle guard to the needle line during the assembly process.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA LRS PLT W/FILTER+SAMPLER+AUTO
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 15363038
• MDR Text Key: 305708080
• Report Number: 1722028-2022-00295
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Catalogue Number: 4823832
• Device Lot Number: 2205132142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 12/22/2022; 12/22/2022
• Supplement Dates FDA Received: 01/05/2023; 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2022
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 55 KG