MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. BD Alaris Microbore Extension Set; Intravascular Administration Set

Catalog Number	10794983
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris microbore extension set had damaged tubing.The following information was provided by the initial reporter: we are still experiencing tubing that is ¿breaking.¿ our clinical staff in cw has most recently reported the following: 4 bi fuse: umid 5371, mfg#: 10794983.Additional information received from the customer: was the fault observed before priming, during priming or after priming the set? most are after priming and standard use please confirm the exact location of the reported fault within the set? at the leur connection did it fall apart at where the tubing connects? yes.What was the impact to the patient? loss of drug; risk of infection.Can you please provide an exact date of event in format dd-mmm-yyyy? too many dates to provide.Risk reports were created.Can you please provide the lot number associated with reported issue? i do not have specific lot numbers as this has occurred over a several month period and the packaging has been thrown out as part of setting up the tubing.Can you please confirm all 4 bi fuse involve same patient or different patients? different patients.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.E.1.Address was not located, and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Alaris Microbore Extension 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 ; +1(847)393-5694
• MDR Report Key: 50933776
• Report Number: 9616066-2026-02463
• Device Sequence Number: 13445434
• Product Code: FPA
• UDI-Device Identifier: 10885403234293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 10794983
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/29/2026
• 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