MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA; STOPCOCK, I.V. SET

Catalog Number	394910
Medical Device Problem Codes	Leak/Splash (1354); Activation, Positioning or Separation Problem (2906)
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 by customer that has been a report of issues with a stopcock used during an emergent er endo case, specifically leaking and not attaching well to the minnesota tube.Verbatim: rcc received a complaint via email.The simulation team called me yesterday with a latent threat that they found with minnesota tubes and the stop cocks.There are 2 versions with the same item number but one is leaking and causing issues.I wasn't sure who to get a hold of.In the two pictures below, the shorter one leaks and is causing issues because it does not connect well.Sounds like we need to get rid of the leaking version somehow.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 2 photos submitted for evaluation.The reported issues of connection issue and leakage were not confirmed upon inspection of the photos.Analysis of the sample showed that the reported defects were not observed.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: CONNECTA
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24327937
• Report Number: 9610847-2026-00062
• Device Sequence Number: 18527013
• Product Code: FMG
• UDI-Device Identifier: 00382903949106
• UDI-Public: (01)00382903949106(11)250908(17)280731(10)5218291
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K974083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

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: Health Professional
• Device Catalogue Number: 394910
• Device Lot Number: 5218291
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 05/29/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/21/2026; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown