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	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd q-syte¿ tri-extension set was blocked while attempting to deliver medication during use.The following information was provided by the initial reporter: "unable to give medication through lumens of q-syte tri extension.Issue seen while giving medications in ot area to pediatric patient.".
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
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 13-jun-2023.H6: investigation summary: it was reported the customer was unable to give medication through the lumens of the q-syte tri-extension set.To aid in the investigation, one unsealed q-syte 15cm small bore tri-extension set was received for evaluation by our quality team.Each extension set was flushed using a luer lock syringe.No occlusion or fluid blockage was detected during the flushing of the device.The syringe was able to connect to the unit properly.A visual inspection did not discover any damage to the tubing or q-syte that could induce the fluid blockage.A device history record review was completed for provided material number 385158, lot 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 process deviations were found.Based on the investigation, the complaint of a leak could not be confirmed.
Event or Problem Description
It was reported that the bd q-syte¿ tri-extension set was blocked while attempting to deliver medication during use.The following information was provided by the initial reporter: "unable to give medication through lumens of q-syte tri extension.Issue seen while giving medications in ot area to pediatric patient.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17070905
• Report Number: 9610847-2023-00135
• Device Sequence Number: 6679407
• Product Code: FPA
• UDI-Device Identifier: 00382903851584
• UDI-Public: 00382903851584
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: NA
• 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): 07/06/2023

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: Other
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 385158
• Device Lot Number: 2122453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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