MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-SYTE; BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE

Catalog Number	385102
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
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
It was reported that bd q-syte ext set, luer-lok 6 in micro bore component damage and leaked the patient, diagnosed with premature infant disease, was administered a needle-free closed infusion connector with a diaphragm valve manufactured by becton dickinson medical devices (shanghai) co., ltd.On (b)(6) 2025.The connector was replaced on (b)(6).On the morning of (b)(6), leakage occurred at the connector during routine saline flushing.Upon close inspection, a rupture in the diaphragm valve was identified.Upon learning of this, the nurse took measures including replacing the septum-type needle-free closed infusion connector.
Additional Manufacturer Narrative
Investigation results: bd was not able to confirm the customer¿s indicated failure mode since no photo nor sample was provided to perform a proper investigation.An investigation on the actual device would be necessary to confirm the reported failure mode.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means pretty low occurrence.No related quality issues or deviations were found during the manufacture of the subassembly batches.

• Brand Name: Q-SYTE
• Common Device Name: BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE
• 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: 24005752
• Report Number: 9610847-2025-00497
• Device Sequence Number: 14639243
• Product Code: FPA
• UDI-Device Identifier: 00382903851027
• UDI-Public: (01)00382903851027(17)290430(10)4180049
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 385102
• Device Lot Number: 4180049
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown