MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE TRI-EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	385162
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd q-syte tri-extension set had leakage issues.The following information was provided by the initial reporter, translated from (b)(6): ¿the anesthesia department has determined that when using the [tri-extension set] connected the 3-way-stopcok.Propofol leaks drop by drop, it does not matter how tight the connection is.It happens with other fluids as well, but because propofol is kind of milky it is also more noticeable.Moreover, the same issue was experienced twice when two 3-way-stopcoks were connected to each other.¿.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 2021-12-16.H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the sample.The sample underwent our internal leakage testing and did not show any signs of leakage.Bd cannot confirm the cause of the failure to our manufacturing process since no defect was observed during leakage testing.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported bd q-syte tri-extension set had leakage issues.The following information was provided by the initial reporter, translated from german: ¿the anesthesia department has determined that when using the [tri-extension set] connected the 3-way-stopcok.Propofol leaks drop by drop, it does not matter how tight the connection is.It happens with other fluids as well, but because propofol is kind of milky it is also more noticeable.Moreover, the same issue was experienced twice when two 3-way-stopcoks were connected to each other.¿.

• Brand Name: BD Q-SYTE TRI-EXTENSION 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12824087
• Report Number: 9610847-2021-00554
• Device Sequence Number: 1492067
• Product Code: FPA
• UDI-Device Identifier: 50382903851626
• UDI-Public: 50382903851626
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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 Expiration Date: 02/28/2022
• Device Model Number: 385162
• Device Catalogue Number: 385162
• Device Lot Number: 9060560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown