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

Catalog Number	42100E-07
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity set had connection issues.The following information was provided by the initial reporter: a brief description of the issue(s) encountered with material #42100e-07.Tubing disconnects even after tightening.The lot number(s) associated with the reported issue.Unable to obtain, packaging had already been discarded in pre-op, the issue occurred in the or.Any patient harm, injury, complication, or negative outcome that occurred as a result of the event(s).1.Blood loss-both occurrences.
Additional Manufacturer Narrative
E.1.Address was not located, and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Six photos were received for quality evaluation.Inspection of the photos indicate that the tubing disconnected from the distal male luer adapter causing a large leakage of blood.The customer complaint of separation was not confirmed, however, the a connection issue was observed.The investigation was forwarded to manufacturing for root cause evaluation.After investigation by manufacturing, and review of the pictures provided by the customer, it was determined that the infusion set did not separate, but the connection was disconnected at the attachment to another product.A root cause could not be determined with the photos provided and no physical sample to examine.The potential cause for the issue seen in the photos is an issue with how the connection was made.The bd clinical team has been contacted in order to determine if the customer needs further use information or training with the product.A device history record review could not be performed because the lot number is unknown.
Additional Manufacturer Narrative
Six photos were received for quality evaluation.Inspection of the photos indicate that the tubing disconnected from the distal male luer adapter causing a large leakage of blood.The customer complaint of separation was not confirmed; however, the a connection issue was observed.The investigation was forwarded to manufacturing for root cause evaluation.After investigation by manufacturing, and review of the pictures and more details of the complaint, the defect was possibly found in the second connection between female luer and male luer due to an incorrect connection between the two components.A manufacturing review was conducted to determine if the assembly process created the issue reported.If the assembler follows the work instructions correctly and uses the correct assembly fixtures, it will detect incorrect assemblies between the connectors.The root cause of separation between female and male luer could be related to an incorrect screwing in between components and not proper use of the fixture by the assembler.The standard work instruction was updated to include the use of a go/no go fixture to verify the correct assembly between the male and female luers.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 23998782
• Report Number: 9616066-2025-04112
• Device Sequence Number: 10530363
• Product Code: FPA
• UDI-Device Identifier: 10885403220609
• UDI-Public: (01)10885403220609
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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: 42100E-07
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 02/11/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/20/2026; 02/13/2026
• 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