MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, MULTIPLS, RBC

Model Number 82416

Device Problems Inadequacy of Device Shape and/or Size (1583); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190); Incomplete or Inadequate Connection (4037)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 06/29/2022

Event Type  Injury  

Manufacturer Narrative

Investigation:a disposable complaint history search was performed for this lot and found one report for similar issues on this lot from the same customer.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the needle stick experienced by the customer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an incident where the operator had a blood exposure from a needle stick from the sampling needle on the sample pouch after collecting donor test samples.During the procedure the technician was accessing the adapter for the tube collection pouch to fill test tubes.The customer has reported that the adapter would not screw tightly over the needle, and had come loose in the technician hand.The technician had been advised to check the sampling needle to make sure that it is secure.The device came loose while the technician was inserting/removing the tube from the device.The technician's middle (second) finger on her right hand was punctured.This resulted in a blood exposure since the donor's blood had been drawn through the needle to fill the tubes prior to the incident.The technician wiped the gloved hand with wipes, washed the area fully; filled out proper paper work and was sent to concentra urgent care per their sop and risk management requirements.She had tubes drawn for serology and was given a tetanus shot as a precaution.The customer declined to provide patient identifier.The product was not returned by the customer for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation:a disposable complaint history search was performed for this lot and found one report for similar issues on this lot from the same customer.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the needle stick experienced by the customer.The technician had been advised to check the sampling needle to make sure that it is secure.The device came loose while the technician was inserting/removing the tube from the device.The technician's middle (second) finger on her right hand was punctured.This resulted in a blood exposure since the donor's blood had been drawn through the needle to fill the tubes prior to the incident.The technician wiped the gloved hand with wipes, washed the area fully; filled out proper paper work and was sent to concentra urgent care per their sop and risk management requirements.She had tubes drawn for serology and was given a tetanus shot as a precaution.The customer declined to share the results of the serology tests due to privacy concern.In 2020, exel (the luer adapter & vacutainer holder supplier) notified terumo bct that they were moving their production of the vacutainer tube holder from italy to china.They provided samples to terumo, and terumo approved the change in august 2021.The first lots of the new vacutainer holders arrived at terumo in november 2021, and were implemented beginning in january 2022.An investigation was conducted and confirmed that the threads on the vacutainer holders are smaller and weaker than the previous version of this part manufactured in italy.Assembly torque, retention torque, and the torque needed to strip the threads are all lower on the new version.Terumo bct supplier engineer contacted the supplier, and notified them of this issue.The supplier agreed to modify the mold and provide samples for testing/approval by terumo prior to release.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a defective vacutainer holder where the threads on the vacutainer holders are smaller and weaker than the previous version manufactured in italy.

Event Description

The customer reported an incident where the operator had a blood exposure from a needle stick from the sampling needle on the sample pouch after collecting donor test samples.During the procedure the technician was accessing the adapter for the tube collection pouch to fill test tubes.The customer has reported that the adapter would not screw tightly over the needle, and had come loose in the technician hand.The technician had been advised to check the sampling needle to make sure that it is secure.The device came loose while the technician was inserting/removing the tube from the device.The technician's middle (second) finger on her right hand was punctured.This resulted in a blood exposure since the donor's blood had been drawn through the needle to fill the tubes prior to the incident.The technician wiped the gloved hand with wipes, washed the area fully; filled out proper paper work and was sent to concentra urgent care per their sop and risk management requirements.She had tubes drawn for serology and was given a tetanus shot as a precaution.The customer declined to provide patient identifier.The product was not returned by the customer for evaluation,.

Event Description

The customer reported an incident where the operator had a blood exposure from a needle stick from the sampling needle on the sample pouch after collecting donor test samples.During the procedure the technician was accessing the adapter for the tube collection pouch to fill test tubes.The customer has reported that the adapter would not screw tightly over the needle, and had come loose in the technician hand.The technician had been advised to check the sampling needle to make sure that it is secure.The device came loose while the technician was inserting/removing the tube from the device.The technician's middle (second) finger on her right hand was punctured.This resulted in a blood exposure since the donor's blood had been drawn through the needle to fill the tubes prior to the incident.The technician wiped the gloved hand with wipes, washed the area fully; filled out proper paper work and was sent to concentra urgent care per their sop and risk management requirements.She had tubes drawn for serology and was given a tetanus shot as a precaution.The customer declined to share the results of the serology tests due to privacy concern.The customer declined to provide the identifier for the trima operator.The product was not returned by the customer for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in b.5, e.3, h.6 and h.10 and corrected information in h.10 and h.6.Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the needle stick experienced by the customer.The technician had been advised to check the sampling needle to make sure that it is secure.The adapter came loose while the technician was inserting/removing the filled vacutainer tube from the device.The technician's middle (second) finger on her right hand was punctured.This resulted in a blood exposure since the donor's blood had been drawn through the needle to fill the vacutainer tubes.The technician cleaned the gloved hand with wipes and washed the area fully; filled out proper paperwork and was sent to urgent care per their sop and risk management requirements.Blood was drawn from the technician for serology and she was given a tetanus shot as a precaution.The customer declined to share the results of the serology tests due to privacy concern.A disposable complaint history search was performed for this lot and found one other report (with 3 occurrences) for similar issues on this lot from the same customer report.Updated investigation: during the procedure the technician was accessing the adapter (comprised of a luer adapter and vacutainer holder) for the tube collection pouch to fill vacutainer tubes in june 2022.The customer has reported seeing three or more incidents (over 2 reports to terumo bct) that the adapter would not screw securely over the needle and had come loose in the technician¿s hand in july 2022.The customer reported these complaints (both this one and the sister report mentioned above) to terumo bct on aug 1, 2022.In august 2022, a cross-functional and cross-site review of the issue was performed, which included the continuous monitoring of customer complaints.An investigation was conducted and found that the threads on the vacutainer holders are smaller and weaker than the previous version of this part manufactured in italy.The first lots of the new vacutainer holders arrived at terumo bct in november 2021 and were included in disposable sets beginning in march 2022.Terumo bct supplier engineering contacted the supplier and notified them of the issue.Terumo bct completed a root cause analysis and concluded that the reason for the weak/small threads on the vacutainer holders was due to the supplier moving manufacturing location from italy to china combined with the introduction of a new injection mold to produce the part.Terumo bct implemented mitigations in its manufacturing processes beginning september 2022.In vietnam, the mitigations initially involved a 100% visual inspection of the thread on the vacutainer holders and shake test prior to use in manufacturing as well as a 100% manual check for loose vacutainer holders in the assembled kits prior to packaging.The shake test was discontinued on september 8, 2022 after it was determined that visual inspection prior to packaging offered a better solution.In costa rica, a 100% visual inspection of the thread on the vacutainer holders were implemented on september 6, 2022.Corrected root cause: a root cause assessment was performed for this complaint.The root cause was determined to be a defective vacutainer holder where the threads on the vacutainer holders are smaller and weaker due to a supplier moving manufacturing location from italy to china combined with the introduction of a new injection mold to produce the part.Corrective action: terumo bct has an existing supplier corrective action for this failure to reduce the potential for recurrence.

• Brand Name: TRIMA ACCEL
• Type of Device: TRIMA PLT + SAMPLER, MULTIPLS, RBC
• 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: 15294933
• MDR Text Key: 298612456
• Report Number: 1722028-2022-00286
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583824164
• UDI-Public: 05020583824164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK190332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 82416
• Device Catalogue Number: 4824162
• Device Lot Number: 2205046142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 10/12/2022; 01/18/2023
• Supplement Dates FDA Received: 10/13/2022; 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2022
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female