MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD EXTENSION SET W/ NON BONDED NEEDLE FREE VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	DYNDTC5077
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd extension set w/ non bonded needle free valve had connection issues.The following information was provided by the initial reporter: it¿s been brought to our attention of an issue with the iv extension sets.There is leakage from the tubing, they seem to be cracking when solutions run through the tube.The leak is occurring during the ct process of adding contrast through the iv connection.Under pressure the connection will start to leak the contrast.Our ems staff recently mentioned that occasionally they will have leaks at the connection point.The ct area is using a power injector to control the flow rate, which is when they sometimes have leaks.Er uses infusion pumps and manual pressure.There are no leaks with the manual pressure.Also, er staff commented that the tubing will sometimes crack near the connection point.On a new package i opened, removing the cap for the connector was difficult and i thought i may have compromised the product.

• Brand Name: BD EXTENSION SET W/ NON BONDED NEEDLE FREE VALVE
• 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: 25696474
• Report Number: 9616066-2026-01688
• Device Sequence Number: 13230576
• Product Code: FPA
• UDI-Device Identifier: 10080196141883
• UDI-Public: (01)10080196141883
• 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: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2026

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: DYNDTC5077
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/07/2026
• 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