MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30914
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that mold was present within the bd alaris¿ extension set cap.The following information was provided by the initial reporter: "black mold or mildew in cap.".
Additional Manufacturer Narrative
H6: investigation summary: one sample of extension set item number 30914 was submitted by the customer for quality investigation.The customer complaint of foreign matter was verified by visual inspection.Evaluation of the sample submitted revealed that there was foreign matter embedded in the safety cap of the distal male luer connector.An attempt to analyze the foreign matter using fourier-transform spectroscopy was attempted, however, the material is embedded into the mold of the safety cap, and cannot be separated.A device history record review for model 30914 lot number 22019365 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14jan2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is an issue with the sterility of the components from the supplier.The supplier investigation indicates that the issue of the foreign matter lies with the supplier of the cap.A quality alert was created to prevent this defect from the safety cap supplier.The supplier has been contacted and made aware of this defect.H3 other text : see h10.
Event or Problem Description
It was reported that mold was present within the bd alaris¿ extension set cap.The following information was provided by the initial reporter: "black mold or mildew in cap.".

• Brand Name: BD ALARIS¿ EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15089469
• Report Number: 9616066-2022-00939
• Device Sequence Number: 4974714
• Product Code: FPA
• UDI-Device Identifier: 10885403233319
• UDI-Public: 10885403233319
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: Other
• Device Expiration Date: 01/14/2025
• Device Catalogue Number: 30914
• Device Lot Number: 22019365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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