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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).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¿ microbore tri-extension experienced device damage while still considered operable.The following information was provided by the initial reporter: 1 out of 3 close septums is locked; unable to open with normal syringe push.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: (b)(6) 2023 investigation summary : our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of component damage - no leak was confirmed upon inspection of the samples.Analysis of the samples showed that the septum of the q-syte sample 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 flow issues and leakage.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
Event or Problem Description
It was reported that the bd q-syte¿ microbore tri-extension experienced device damage while still considered operable.The following information was provided by the initial reporter: 1 out of 3 close septums is locked; unable to open with normal syringe push.

• 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: 16039667
• Report Number: 9610847-2022-00501
• Device Sequence Number: 6218764
• 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): 02/15/2023

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: 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: 12/05/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/06/2023
• 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