MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTOR; FOR COLLECTION OF PLATELETS WITH OPTIONAL PLASMA. FOR PLATELET STORAGE IN PLASMA

Model Number	4R2352
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per the arc capa quality engineer, supplier quality: i wanted to let you know that i opened a new nsepd today associated with a positive bact case which was determined to be reportable to the fda as a polymicrobial positive (2 or more bacterial species) was detected in the bacterial testing of a platelet collection.The two organisms identified were: staphylococcus epidermidis and staphylococcus hominis.This unit was collected (b)(6) 2025 at the columbia sc blood donation center, lot number fa24k07193.The involved phlebotomist subsequently was observed following proper arm scrub procedures.There are no samples available.Fresenius kabi has completed the following investigations.All batch reviews related to this incident were performed with satisfactory results.No issues were identified during the batch reviews that could contribute to the reported issue.All retention sample reviews related to this incident were performed with satisfactory results.No issues were identified during the retention sample reviews that could contribute to the reported issue.No additional positive bact complaints have been received for the reported amicus kit batch fa24k07193.Based on this analysis, fresenius kabi did not identify any evidence indicating that the reported contamination originated from fresenius kabi product or fresenius kabi manufacturing facilities.We are reporting conservatively based on the nature of the reported complaint.
Event or Problem Description
Staphylococcus epidermidis and staphylococcus hominis were not recovered on the manufacturing areas where the product can be directly exposed and were also not recovered in the associated products to the complaint.Staphylococcus genera are well known to be highly sensitive to the disinfectant used in maricao, which reduces the possibility that the organisms found as part of the complaint originated at the fresenius kabi maricao site.Additionally, the sterilization records were verified, and confirmed no aberrations or situations that could have compromised the sterilization process during the manufacturing process of the lots associated with the complaints.These organisms are well known to be highly susceptible to high temperatures.All products manufactured at the maricao site undergo terminal heat sterilization cycles that warrant a sterility assurance -level (sal or probability of nonsterile unit) of 10-6.The d values for staphylococcus epidermidis and staphylococcus hominis ensure that these organisms will not survive the validated sterilization cycles at maricao site.In order for a contaminated product at a hospital to be caused by a product in which maricao is the source, the following conditions must be met: 1) the bacteria must be present in the maricao clean room during the manufacturing process (organisms were not identified in the clean room areas during the manufacturing of the products), 2) be able to enter the product (organisms were not identified as part of the bioburden process), 3) survive thermal steam sterilization.D values of these organisms ensure they will not survive the sterilization process.Based on the data evaluated, it is highly improbable that the maricao manufacturing process is the source for the reported complaint.A source that could contribute to the bacterial contamination reported in the complaint was not identified during the investigation of the manufacturing process at fresnius kabi maricao.The sterilization processes were satisfactorily performed according to their respective specifications.Therefore, the sterilization processes are not considered a possible root cause for the reported complaint.Based on the data evaluated, it can be concluded that the microorganisms staphylococcus epidermidis and staphylococcus hominis were not related to the batches associated in this complaint.The in-process and finished product testing of the maricao products involved in this complaint complied with all quality release criteria at the time of disposition.Bioburden, bacterial endotoxin (bet) tests and the sterilization parameters were within limits.The microorganism trending was conducted from (b)(6) 2024 and no staphylococcus hominis and staphylococcus epidermidis was identified in the product bioburden test at fresenius kabi haina.Based on this analysis, and the analysis previously communicated on the initial mdr, fresenius kabi did not identify any evidence indicating that the reported contamination originated from fresenius kabi product or fresenius kabi manufacturing facilities.This mdr was reported conservatively based on the nature of the reported complaint.

• Brand Name: AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTOR
• Common Device Name: FOR COLLECTION OF PLATELETS WITH OPTIONAL PLASMA. FOR PLATELET STORAGE IN PLASMA
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502913
• MDR Report Key: 22329084
• Report Number: 3004548776-2025-00292
• Device Sequence Number: 9483028
• Product Code: GKT
• UDI-Device Identifier: 00810020440713
• UDI-Public: 00810020440713
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: BK960005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 4R2352
• Device Catalogue Number: 4R2352
• Device Lot Number: FA24K07193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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
• Patient Sex: Unknown