MAUDE Adverse Event Report: BECTON DICKINSON Q-SYTE 15CM SMALL BORE BI-EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385157
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
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
There was a cardiac patient in cath-lab, the patient was connected with q-syte bi exertion and pmo line to a syring pump.During the process blood back flow happened from one of the extension of bd q-syte to pmo line till half way of pmo line.
Additional Manufacturer Narrative
Additional information: (d) provided lot #, device expiration date, and full udi.(h) added device manufacture date.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.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.No related quality issues or deviations were found during the manufacture of the subassembly batches.
Event or Problem Description
No additional information.

• Brand Name: Q-SYTE 15CM SMALL BORE BI-EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 23390508
• Report Number: 9610847-2025-00382
• Device Sequence Number: 9945303
• Product Code: FPA
• UDI-Device Identifier: 00382903851577
• UDI-Public: (01)00382903851577(11)250115(17)271130(10)4337401
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: 385157
• Device Lot Number: 4337401
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown