MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD 9.5 INCH EXT W/1 VLV PORT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30201E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 9.5 inch ext w/1 vlv port had separated.The following information was provided by the initial reporter: line came apart when attached to the patient.It disconnected at a location that should be fused together.Patient was exposed to risk as line fell apart while connected to patient.Patient bleed out of the disconnected line.Anesthetic tech left sample in the tech room - line is contaminated.
Additional Manufacturer Narrative
Investigation result: one 30201e sample was returned for investigation in opened packaging from lot 23099328; blood was present in the set.The customer reported that "line came apart when attached to the patient.It disconnected at a location that should be fused together.Patient was exposed to risk as line fell apart while connected to patient.Patient bleed out of the disconnected line." a visual inspection confirmed the customer's experience; the tubing separated at the y-site tubing joint and no obvious signs of solvent were visible at the affected 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 23099328 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, since the manufacture of the reported lot, the product has been transferred to an alternative manufacturing site; however quality team will continue to monitor the incoming feedback and remain vigilant to reports of this nature.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 30201e product over the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD 9.5 INCH EXT W/1 VLV PORT
• 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: 23842543
• Report Number: 9616066-2025-03830
• Device Sequence Number: 9835317
• Product Code: FPA
• UDI-Device Identifier: 07613203011556
• UDI-Public: (01)07613203011556(17)260922(10)23099328
• 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): 01/30/2026

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 Expiration Date: 09/22/2026
• Device Catalogue Number: 30201E
• Device Lot Number: 23099328
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown