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

Catalog Number	10016073
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris secondary gravity set had connection issues.The following information was provided by the initial reporter: the staff is having difficulty connecting and disconnecting the spike from the smaller med bags that come from pharmacy.This is causing staff frustration, risk of harm when they finally get the spike out and they are flailing, and waste as they are opting to just get another tubing set for each new bag.The spike is puncturing the iv bag upon insertion.Difficulty removing the spike from the smaller med bags.One instance of the spike puncturing the iv bag when a patient was in transport.The specific dates of occurrence are unknown.Lot number is unknown.No adverse events as a result of the reported issues.Additional information received from the customer: please provide a detailed description of the reported issue: ¿the spike is puncturing the iv bag upon insertion.¿ is this not part of the normal procedure, or does this indicate a problem? during the normal spiking procedure, the sharp spike is puncturing the bag beyond just spiking into the bag as normal.On a call last week with the customer, we reviewed steps to help prevent this from occurring.
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.

• Brand Name: BD ALARIS SECONDARY 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: 24193230
• Report Number: 9616066-2026-00137
• Device Sequence Number: 12778696
• Product Code: FPA
• UDI-Device Identifier: 10885403230110
• UDI-Public: (01)10885403230110
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: MR
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 10016073
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 05/04/2026
• 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