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

Catalog Number	515085
Medical Device Problem Codes	Defective Component (2292); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unspecified bd infusion set was damaged the following information was received by the initial reporter with the following vebratim it was reported by customer that blue clamps arent locking.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that the reported event was not reportable to the fda as it is not likely to cause or contribute to serious injury or death.If we receive any information that changes this decision, another follow up mdr will be submitted.
Event or Problem Description
Additional information please share the material & lot number associated with reported issue we do not have the specific lot number for the associated clamps sample available is mentioned as yes, please provide the address of the facility for us to ship the return label please ship the return label to (b)(6) at what point did this failure occur? beginning stage, they would not clamp around the patients connection site, leading us to have to get a new clamp what was the medication type and duration of the infusion? it was a multitude of different medications as the collection of clamps is upward 10 did the patient receive a combination of any medications? unaware, and the clamp wasn¿t in use as we had to use another one, but this was on multiple different patients what product was the set connected to? some were pumps, some were lines and some were direct to huber needle how long has this product been used in your facility? since march was there any leak? there is no leak, these are infusion clamps.

• Brand Name: PHASEAL
• 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: 22560709
• Report Number: 9616066-2025-02068
• Device Sequence Number: 9528730
• Product Code: KMK
• UDI-Device Identifier: 00382905150852
• UDI-Public: (01)00382905150852
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: 515085
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown