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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd q-syte¿ tri-extension set septum was blocked.This occurred 20 times each in lots 2033442, 2060348, and 2122453.The following information was provided by the initial reporter: "during a discussion with the customer, the healthcare worker found that the silicon septum entrance (hub) of q-syte tri extension small bore was blocked.Have to create another indent by healthcare worker due to this blocked septum".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2033442 d.4.Medical device expiration date: 31-jan-2025 h.4.Device manufacture date: 21-feb-2022 d.4.Medical device lot #: 2060348 d.4.Medical device expiration date: 28-feb-2025 h.4.Device manufacture date: 29-apr-2022 d.4.Medical device lot #: 2122453 d.4.Medical device expiration date: 30-apr-2025 h.4.Device manufacture date: 17-may-2022 h.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd q-syte¿ tri-extension set septum was blocked.This occurred 20 times each in lots 2033442, 2060348, and 2122453.The following information was provided by the initial reporter: "during a discussion with the customer, the healthcare worker found that the silicon septum entrance (hub) of q-syte tri extension small bore was blocked.Have to create another indent by healthcare worker due to this blocked septum".
Additional Manufacturer Narrative
H6: investigation summary: it was reported the silicon septum entrance of the q-syte was blocked.As a sample was not returned, a thorough sample investigation could not be completed.Investigation of the actual sample would be necessary to confirm the reported failure mode.A device history record review was completed for provided material number 385158, lot numbers 2033442, 2060348 and 2122453.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.Additional device histories were reviewed for each batch of q-sytes used in the manufacturing of this batch and no related quality issues or deviations were found during the manufacture of the subassembly batches.Based on the investigation, bd was not able to confirm the customer¿s indicated failure mode.

• 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17024579
• Report Number: 9616066-2023-01033
• Device Sequence Number: 20550959
• 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): 06/16/2023

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 Catalogue Number: 385158
• Device Lot Number: SEE H10
• 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: 05/06/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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