MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE 15CM SMALL BORE BI-EXT SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	385157
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Street address exceeds characters limit: (b)(6).
Event or Problem Description
It was reported that bd q-syte 15cm small bore bi-ext set spin collar does not lock.The following information was provided by the initial reporter: incident happened in er department where after cannulation staff attached qsyte bi extension cat no 385157 on iv catheter 18 g and when they tried to lock extension by rotating spin nut it got freed during tightening of it hence causing risk of accidental dislodgement of catheter, they faced this complaint twice changed the qsyte with new qsyte biextension.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 photo, 1 video and 2 physical samples submitted for evaluation.The reported issue of connection issues was confirmed upon inspection and testing of the samples.Analysis of the sample showed that the male luer does not tighten correctly, the collar keeps rotating and does not tighten the connection.Bd determined that the cause of the failure was the supplier of the extension set.The physical samples received were tested by connecting the extension set to the unknown catheter, where the failure mode was confirmed.The extension set does not tighten, however does need a higher force to disconnect the devices.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.
Event or Problem Description
No additional information.

• Brand Name: BD Q-SYTE 15CM SMALL BORE BI-EXT SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 22028187
• Report Number: 9610847-2025-00143
• Device Sequence Number: 8112501
• Product Code: FPA
• UDI-Device Identifier: 00382903851577
• UDI-Public: (01)00382903851577
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 4232699
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown