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

Catalog Number	72215N
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris secondary set had foreign matter in the fluid path.The following information was provided by the initial reporter: we received complaint from customer on the contaminated secondary giving set encountered in one of their clinical units.The issue appears to be a dirty section of adhesive tape around the spike.
Additional Manufacturer Narrative
Investigation result: no 72215n sample was available for investigation.The customer did not provide any lot information and reported "on the contaminated secondary giving set encountered in one of their clinical units" and that "the issue appears to be a dirty section of adhesive tape around the spike." the photograph provided by the customer confirmed their experience, with a piece of adhesive tape present on the spike cap, with parts of it appearing blackened.The details of this feedback were forwarded to the manufacturing site and the supplier for investigation.A definitive cause for the customer's experience could not be determined during analysis of the manufacturing process; no tape is used in the cleanroom, furthermore the product is subjected to visual inspections during the manufacturing process for such issues.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Although it was not possible to determine a definitive cause for the customer's experience, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 72215n product in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24073941
• Report Number: 9616066-2025-04195
• Device Sequence Number: 16048702
• Product Code: FPA
• UDI-Device Identifier: 10885403235467
• UDI-Public: (01)10885403235467(10)UNKANOWN
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 72215N
• Device Lot Number: UNKNOWN
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown