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	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
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 there were flow issues and blockages.There was no report of patient impact.The following information was provided by the initial reporter: bd q-syte small bore tri ext.2 lumen blocked.In icu bd q-syte tri ext.Is getting used, and septum is closed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 01-feb-2023.H6.Investigation summary: our quality engineer inspected the 1 tri-extension set returned with 4 q-syte samples, one was a standalone, and 1 photo submitted for evaluation.The reported issue of flow issues - fluid blockage was confirmed upon inspection of the samples.Analysis of the samples showed that 1 of the q-sytes samples did not have the proper slit opening.Bd determined that the cause of the failure was associated to the manufacturing process.During the manufacturing process the septums of the q-sytes have a slit cut into them via a blade.If the blade is dull, broken, or missing in the manufacturing machinery than the slit will not be properly cut into the septum resulting in the reported defect.Production records were reviewed, and this batch met our manufacturing specification requirements.
Event or Problem Description
It was reported while using bd q-syte¿ microbore tri-extension there were flow issues and blockages.There was no report of patient impact.The following information was provided by the initial reporter: bd q-syte small bore tri ext.2 lumen blocked.In icu bd q-syte tri ext.Is getting used, and septum is closed.

• 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 ; 8015296192
• MDR Report Key: 16359736
• Report Number: 9610847-2023-00025
• Device Sequence Number: 6873344
• 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): 03/15/2023

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: 05/31/2024
• Device Catalogue Number: 385158
• Device Lot Number: 1151553
• 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: 01/21/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/11/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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