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

Catalog Number	42490E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity set had separated.The following information was provided by the initial reporter: tubing separated from injection port during use.
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.
Additional Manufacturer Narrative
Investigation result: one 42490e sample was received with packaging from lot 25045075 for investigation; fluid was present in the set.The customer reported that the "tubing separated from injection port during use".Visual inspection of the returned sample confirmed the customer's experience where the upstream y-site separated from the rest of the set.Upon closer inspection, no obvious signs of solvent were observed at the affected tubing joint.The details of this feedback were forwarded to the manufacturing site for investigation.Their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the tubing joint during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 25045075 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 42490e product in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: 22634571
• Report Number: 9616066-2025-02142
• Device Sequence Number: 18410471
• Product Code: FPA
• UDI-Device Identifier: 07613203010894
• UDI-Public: (01)07613203010894(10)25045075
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/05/2025

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: 42490E
• Device Lot Number: 25045075
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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