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

Catalog Number	10013902
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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 alaris smartsite low sorbing set had separated.The following information was provided by the initial reporter: after the patient was rolled onto bedpan, it was discovered that the pigtail on the filter attached to the remodulin drip had dislodged and now in 2 pieces.The medication was no longer connected to her, and her picc line had backed up with blood.Another filter was within reach, and the line was quickly re-assembled with a newly primed filter.After pulling waste, replacing the clave, and preparing her picc, the patient was off the medication approximately 10-15 minutes.She did not have any complications as a result.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual examination of the sample indicates that the sample separated at the outlet port to the tubing.Further examination of the sample, under magnification, indicate a lack of solvent on the bonding surfaces.The customer complaint of separation was confirmed.Investigation has been forwarded to manufacturing for root cause analysis.It is possible that the issue could be caused by a lack of solvent on the bonding surfaces due to an incorrect insertion of the tubing to the solvent dispenser, however, inspection of the sample indicates that there is evidence of solvent application to the tubing and the filter port, and there appears to be blood on the the sample indicating that the tubing was in use prior to the failure.Based on the investigation of the sample and description of the failure, a definitive root cause could not be determined.A device history record review could not be performed because the lot number is unknown.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING 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: 22945713
• Report Number: 9616066-2025-02633
• Device Sequence Number: 9755493
• Product Code: FPA
• UDI-Device Identifier: 10885403233814
• UDI-Public: (01)10885403233814(10)H370100139021
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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: 10013902
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/13/2025
• 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