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

Catalog Number	MP1000-C
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus needleless connector had connection issues.The following information was provided by the initial reporter: product issue # mp-1000-c the picc line was noted to be backing up with blood.Attempted to clean connection to connect flush to flush line, during scrub the hub the junction between the t-piece and the clave (blue needless port) disconnected.I was able to keep it sterile and cleaned ends and replaced t-piece and clave, flush line adequately and hook up triport and iv tubing to keep infusion going.When entered second time to respond to beeping iv pump (med infusion had ended) the picc line was backed up again, further this time, past clave and into the triport.When connections were traced up the line to find the breakage, the medline had disconnected from the clave (blue needless port) that the med syringe was connected to.Med tubing was discontinued, and new triport and medline attached.Md notified and no further issues reported that shift.
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
H10: one set model mp1000-c, one bd standalone needless connector and one bd smartsite trifuse set was returned for investigation.The sets were examined for defects and abnormalities.The trifuse spin collar was cracked.No other defects or abnormalities were observed.The customer complaint of a connection issue was verified.The most probable cause is that the alcohol swab caused the spin collar to become brittle and crack.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
No additional information was provided.

• Brand Name: BD MAXPLUS 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: 24319836
• Report Number: 9616066-2026-00314
• Device Sequence Number: 13113693
• Product Code: FPA
• UDI-Device Identifier: 10885403223228
• UDI-Public: (01)10885403223228
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072542
• 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): 04/27/2026

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: MP1000-C
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/27/2026
• 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