MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ VIAL ACCESS ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385108
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.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 yellowish foreign matter was found inside the middle chamber of the bd q-syte¿ vial access adapter.The following information was provided by the initial reporter: "it has been noted to have a yellowish substance in one of the chambers ( middle chamber ) in this product.It was reported by a co-worker.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: (b)(6) 2023.Investigation summary : our quality engineer inspected the 5 samples submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the samples.Analysis of the samples showed that there was excessive adhesive on the samples.This catalog is glued together in the union between the vial adapter and the q-syte assembly.What is being observed is uncured adhesive, which has normal color of a yellow tone.Sometimes when there is an excessive amount of adhesive it may not cure completely causing the yellowish tone.The excess adhesive does not affect the functionality of the device.Production records were reviewed, and this batch was in compliance with our product specification requirements.
Event or Problem Description
It was reported that yellowish foreign matter was found inside the middle chamber of the bd q-syte¿ vial access adapter.The following information was provided by the initial reporter: "it has been noted to have a yellowish substance in one of the chambers ( middle chamber ) in this product.It was reported by a co-worker.".

• Brand Name: BD Q-SYTE¿ VIAL ACCESS ADAPTER
• 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: 15902251
• Report Number: 9610847-2022-00448
• Device Sequence Number: 17419073
• Product Code: FPA
• UDI-Device Identifier: 00382903851089
• UDI-Public: (01)00382903851089
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013621
• 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): 02/03/2023

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: 02/28/2026
• Device Catalogue Number: 385108
• Device Lot Number: 1053411
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2021
• 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