MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ MICROBORE TRI-EXTENSION; 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	03/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd q-syte¿ microbore tri-extension the connection was difficult.There was no report of patient impact.The following information was provided by the initial reporter: when the user is trying to prime the q syte tri extension 385158, not able to prime two lumens due to resistance in septum and not able to connect posiflush lue lok to q syte.Already raised the same complaint with respect to other batch few months back.
Event or Problem Description
It was reported while using bd q-syte¿ microbore tri-extension the connection was difficult.There was no report of patient impact.The following information was provided by the initial reporter: when the user is trying to prime the q syte tri extension 385158, not able to prime two lumens due to resistance in septum and not able to connect posiflush lue lok to q syte.Already raised the same complaint with respect to other batch few months back.
Additional Manufacturer Narrative
H6: investigation summary it was reported the customer was not able to prime two lumens due to resistance in the septum and was not able to connect a flush.As a sample was not returned, a thorough sample investigation could not be completed.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), capa¿s 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.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¿ MICROBORE TRI-EXTENSION
• 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: 16638980
• Report Number: 9610847-2023-00076
• Device Sequence Number: 20449346
• Product Code: FPA
• UDI-Device Identifier: 00382903851584
• UDI-Public: (01)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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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