MAUDE Adverse Event Report: TERUMO BCT RIKA; RIKA PLASMA SEPARATION SET

Catalog Number	6212001
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that a donor was on donor floor waiting for the venipuncture process in the bed.The donor mentioned while she was waiting, she felt liquid in her face, but didn't pay attention until the liquid was consistently splashing on her face and hands and close to her eyes and mouth.She called the phlebotomist to inform the event.During the investigation it was found that the separation set on the adjacent donor had a pinhole that produced a plasma splash.The donor was instructed by the supervisor to wash their face and hands.It was reported that the donor went to the emergency room to be evaluated and is under medication.Terumo bct is awaiting return of the disposable set for evaluation.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11.Investigation: on 12/23/25, the customer referred to case (b)(4) which contains documents of a photo and separation set diagram describing the location of the leak.A photograph was submitted in lieu of the disposables set to aid in the investigation.Upon review, the reported allegation was confirmed.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot 2504012161 and found no other report for similar issues.The lot referenced in the complaint had only one occurrence of a leak in this area.However, leaks attributed to damage from flow wrapping issues or other forms of damage have been observed in additional complaint records.Correction: this specific incident was escalated to the relevant manufacturing personnel for awareness.As part of our ongoing post market compliance activities, terumo bct will continue to monitor for this type of event.Appropriate action will be taken if a trend is identified per our internal processes.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that a donor was on donor floor waiting for the venipuncture process in the bed.The donor mentioned while she was waiting she felt liquid in her face, but didn't pay attention until the liquid was consistently splashing on her face and hands and close to her eyes and mouth.She called the phlebotomist to inform the event.During the investigation it was found that the separation set on the adjacent donor had a pinhole that produced a plasma splash.The donor was instructed by the supervisor to wash their face and hands.It was reported that the donor went to the emergency room to be evaluated and is under medication.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.Upon review, the reported allegation was confirmed.A review of the device history record (dhr) for this lot showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot 2504012161 and found no other report for similar issues.The lot referenced in the complaint had only one occurrence of a leak in this area.However, leaks attributed to damage from flow wrapping issues or other forms of damage have been observed in additional complaint records, none of which meet the criteria for reportability.Correction: this specific incident was escalated to the relevant manufacturing personnel for awareness.Root cause: a root cause assessment was performed for this complaint.The tubing defect is consistent with the material getting caught in the end seal of the flow wrap packaging, this could arise due to:*improper packaging of tubing during final assembly resulting in tubing being out of place or increasing the overall length of the tubing.*error in manual loading of final tubing assembly on the flow wrap machine.*accidental adjustment of the set location as it goes through flow wrapper.
Event or Problem Description
The customer reported that a donor was on donor floor waiting for the venipuncture process in the bed.The donor mentioned while she was waiting she felt liquid in her face, but didn't pay attention until the liquid was consistently splashing on her face and hands and close to her eyes and mouth.She called the phlebotomist to inform the event.During the investigation it was found that the separation set on the adjacent donor had a pinhole that produced a plasma splash.The donor was instructed by the supervisor to wash their face and hands.It was reported that the donor went to the emergency room to be evaluated and is under medication.The collection set is not available for return because it was discarded by the customer.

• Brand Name: RIKA
• Common Device Name: RIKA PLASMA SEPARATION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: verenia oliver ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 24081962
• Report Number: 1722028-2026-00018
• Device Sequence Number: 15926665
• Product Code: GKT
• UDI-Device Identifier: 05020583212008
• UDI-Public: 05020583212008
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: BK241097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 6212001
• Device Lot Number: 2504012161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/27/2026; 04/20/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/05/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White