MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP5310-C
Medical Device Problem Codes	Disconnection (1171); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus pressure rated extension set with needleless connector had separated.The following information was provided by the initial reporter: i'm reaching out regarding 2 safety incidents that involved bd item#: mp5310-c (pressure-rated iv extension set, purple striped, with removable maxplus clear needle-free connector, spin male luer lock, and mini bore tubing, 0.59 ml pv, 8.5" length): sr: 52131 (happened on (b)(6) 2026), harm level- 0-no harm - did not reach patient/person- nurse was disconnecting iv tubing from j loop, connector snapped off and became dislodged in j loop.Blood began to back up into tubing.Tubing was immediately removed from patient since nurse was present as this occurred.Tubing was thrown out and new iv set up was primed.
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
Investigation results: due to no sample being received, an investigation could not be performed, and a root cause could not be determined.No product will be returned per customer.No investigation was performed.
Event or Problem Description
No additional information.

• Brand Name: BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 24490040
• Report Number: 9616066-2026-00549
• Device Sequence Number: 10676697
• Product Code: FPA
• UDI-Device Identifier: 10885403236686
• UDI-Public: (01)10885403236686
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K083472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: MP5310-C
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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