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

Catalog Number	385158
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the iv set separated from the bd q-syte¿ tri-extension set's split-septum during the infusion.This occurred with 3 extension sets.The following information was provided by the initial reporter: "iv set getting slipped from split septum of qsyte tri extension set, inability to continue infusion".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary it was reported the iv set slips from the split septum of the q-syte tri-extension set.To aid in the investigation, one video was provided for evaluation by our quality team.In the video, disconnection can be observed on the device.However, the instructions for use state, "attach the extension set to the hub of the vascular access catheter by inserting the luer into the hub and rotating until a secure connection is made.Do not overtighten." in the video, on the insertion of the luer can be observed, but there is no rotating action to secure the connection.It could be possible the customer was not using the product as intended.An evaluation of the physical sample would be necessary to determine if there is any other defect in the component inducing the disconnection.A device history record review was completed for provided material number 385158, lot 3032599.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), capas or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Based on the investigation, bd was able to confirm the customer¿s indicated failure mode but is likely due to an incorrect method of connection.See h10.
Event or Problem Description
It was reported that the iv set separated from the bd q-syte¿ tri-extension set's split-septum during the infusion.This occurred with 3 extension sets.The following information was provided by the initial reporter: "iv set getting slipped from split septum of qsyte tri extension set, inability to continue infusion".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17638394
• Report Number: 9610847-2023-00240
• Device Sequence Number: 7978899
• Product Code: FPA
• UDI-Device Identifier: 00382903851584
• UDI-Public: 00382903851584
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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: 01/31/2026
• Device Catalogue Number: 385158
• Device Lot Number: 3032599
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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