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

Catalog Number	B2-70072
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd admin set had foreign matter.The following information was received by the initial reporter with the following verbatim.It was reported by customer that they found foreign material on the administration set.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported that they found foreign material on the administration set.One photo was taken by the customer that verifies the issue and a quality notification was sent to the supplier.From the supplier's investigation, there were no records of parts with surface dirtiness and they have verified the cleaning of the molds have all been done according to the schedule.The cause is unknown.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
Material # b2-70072.Batch # 23115265.It was reported by customer that they found foreign material on the administration set.Rcc received a complaint via email.Foreign material found on administration sets.Product#: b2-70072.Lot#: 23115265.
Additional Manufacturer Narrative
It was reported that they found foreign material on the administration set.Customer was unable to provide sample(s) therefore an investigation was conducted based on the one photo provided by the customer.The photo verifies the issue and a quality notification was sent to the supplier.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.From the supplier's investigation, a batch review was performed on the lots.No notification for parts with surface dirtiness.The cleanings of the mold were verified and all have been done according to the scheduled maintenance.The contamination could be grease from the mold which is a food grade grease approved by nsf.Per the quality agreement with the supplier, the quantity reported with the defective condition does not exceed 130 ppms as established, so it is a residual risk of the supplier's process, no action required.Manufacturing review from the quality assurance team at the bd tijuana facility confirmed that the spike cap is not removed during assembly of the finished good.
Event or Problem Description
No additional info.

• Brand Name: BD ADMIN 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20708269
• Report Number: 9616066-2024-01677
• Device Sequence Number: 9604222
• Product Code: FPA
• UDI-Device Identifier: 10814371020195
• UDI-Public: (01)10814371020195(11)231114(17)261114(10)23115265
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2025

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: Other
• Device Catalogue Number: B2-70072
• Device Lot Number: 23115265
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/27/2025; 04/28/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/28/2025; 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown