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

Model Number	385108
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.E.4.The initial reporter also notified the fda on 2-jun-2023.Medwatch report # mw5118458.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd q-syte¿ vial access adapter the adapter was damaged and leakage occurred.There was no patient impact.The following information was provided by the initial reporter: pt advised she has had multiple defective adapters that haven't clicked onto the vial and have caused leaking and wasting of cassettes.Pt wanted to know if this was something we had noticed with patients recently.No missed doses or adverse event reported.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of defective adapters / leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.See h10.
Event or Problem Description
It was reported that during use with bd q-syte¿ vial access adapter the adapter was damaged and leakage occurred.There was no patient impact.The following information was provided by the initial reporter: pt advised she has had multiple defective adapters that haven't clicked onto the vial and have caused leaking and wasting of cassettes.Pt wanted to know if this was something we had noticed with patients recently.No missed doses or adverse event reported.

• 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 ; 8448235433
• MDR Report Key: 17346815
• Report Number: 9610847-2023-00182
• Device Sequence Number: 6912816
• Product Code: FPA
• UDI-Device Identifier: 00382903851089
• UDI-Public: (01)00382903851089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2023

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: Lay User/Patient
• Device Model Number: 385108
• Device Catalogue Number: 385108
• Device Lot Number: UNKNOWN
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female