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

Model Number	385163
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd q-syte¿ bi-extension sets had leakage issues, resulting in a second chemo dose being necessary.The following information was provided by the initial reporter: "the bd q-syte bi-extension set was leaking (three incidences) while connected to a port needle (polyflon make from competitor)this happened while infusing chemo using an infusion pump.".
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of leaks at connection to another set was not confirmed upon inspection and testing of the sample.No abnormal conditions or damages were observed on the sample.The sample also underwent our internal leakage testing and no signs of leakage were observed.A manufacturing root cause was not determined since the reported failure was not confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported 3 bd q-syte¿ bi-extension sets had leakage issues, resulting in a second chemo dose being necessary.The following information was provided by the initial reporter: "the bd q-syte bi-extension set was leaking (three incidences) while connected to a port needle (polyflon make from competitor)this happened while infusing chemo using an infusion pump".

• Brand Name: BD Q-SYTE¿ BI-EXTENSION SET
• 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: 14135538
• Report Number: 9610847-2022-00143
• Device Sequence Number: 17150031
• Product Code: FPA
• UDI-Device Identifier: 50382903851633
• UDI-Public: 50382903851633
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K142527
• 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): 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: 385163
• Device Catalogue Number: 385163
• Device Lot Number: 1193264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown