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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd q-syte¿ microbore tri-extension there was a blockage.This occurred 150 times.There was no report of patient impact.The following information was provided by the initial reporter: during priming of q syte tri extension lumens, user can prime only one lumen and rest two lumens are not able to prime.When user secure bd posiflush and trying to prime they are not able to push the plunger as there is a resistance.Again if they try to connect posiflush we can see rebound of posiflush.
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15-dec-2022.Our quality engineer inspected the 4 unsealed samples and 3 videos submitted for evaluation.The reported issues of flow issues - fluid blockage was confirmed upon inspection of the samples.Analysis of the samples showed that at least one extension of each of the q-syte samples did not have the proper slit openings across the septum.Bd determined that the cause of the failure was associated to the manufacturing process.During the manufacturing process the disks 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 disk resulting in flow issues and leakage.Production records were reviewed, and this batch was in compliance with our product specification requirements.H3 other text : see h10.
Event or Problem Description
It was reported while using bd q-syte¿ microbore tri-extension there was a blockage.This occurred 150 times.There was no report of patient impact.The following information was provided by the initial reporter: during priming of q syte tri extension lumens, user can prime only one lumen and rest two lumens are not able to prime.When user secure bd posiflush and trying to prime they are not able to push the plunger as there is a resistance.Again if they try to connect posiflush we can see rebound of posiflush.

• 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: 15998733
• Report Number: 9610847-2022-00478
• Device Sequence Number: 15095705
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: Other
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 385158
• Device Lot Number: 2033442
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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