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

Catalog Number	385157
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
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 the bd q-syte 15cm small bore bi-ext set had a loose connection.The following information was provided by the initial reporter: the luer lock plug keeps rotating and gets disconnected soon after securing.Additional information provided: 1.Can you confirm is there any patient impacted? - yes,there was a blood spillage for one patient, incident report has been raised by the staff nurse.2.Can you confirm that there are any serious injuries that occur to the patient? - no serious injuries.3.What is the current nurse status? is she/he ok? - nurse is fine.4.Quantity involved - (b)(4) quantities in total of the same batch.5.Date of occurrence- (b)(6) 2025.There was a type in the date of occurrence, it is (b)(6) 2025.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 3 photos submitted for evaluation.The reported issue of connection issue was not confirmed upon inspection of the samples.Analysis of the sample showed that no damage or trouble with the connection was observed.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.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.
Event or Problem Description
Additional information provided: 1.Can you confirm is there any patient impacted? - yes, there was a blood spillage for one patient, incident report has been raised by the staff nurse.2.Can you confirm that there are any serious injuries that occur to the patient? - no serious injuries.3.What is the current nurse status? is she/he, ok? - nurse is fine.4.Quantity involved - (b)(4) quantities in total of the same batch.5.Date of occurrence- 23/05/2025.There was a typepo in the date of occurrence, it is 23/04/2025.

• Brand Name: BD Q-SYTE 15CM SMALL BORE BI-EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION 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: 21981528
• Report Number: 9610847-2025-00133
• Device Sequence Number: 17215364
• Product Code: FPA
• UDI-Device Identifier: 00382903851577
• UDI-Public: (01)00382903851577(11)240819(17)270731(10)4214805
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 4214805
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown