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

Model Number	385101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
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.Date of event: unknown.The date received by manufacturer has been used as a default.
Event or Problem Description
It was reported bd q-syte extension set leaked at the luer connection.The following information was provided by the initial reporter: "leakage from q-syte and extension tube luer-port".
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.Date of event: unknown.The date received by manufacturer has been used as a default.
Event or Problem Description
It was reported bd q-syte extension set leaked at the luer connection.The following information was provided by the initial reporter: "leakage from q-syte and extension tube luer-port".
Additional Manufacturer Narrative
H6: investigation: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue was not confirmed upon inspection of the photo.No damages or defects that could result in leakage were observed in the supplied photo.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.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 bd q-syte extension set leaked at the luer connection.The following information was provided by the initial reporter: "leakage from q-syte and extension tube luer-port".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 11-mar-2022.H6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the sample.During inspection no damages or abnormalities were observed on the sample.The sample was functionally tested for the reported defect of leakage and during testing the sample showed no signs of leakage.Bd cannot determine a manufacturing root cause of the failure since the defect was not confirmed during testing.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
Event or Problem Description
It was reported bd q-syte extension set leaked at the luer connection.The following information was provided by the initial reporter: "leakage from q-syte and extension tube luer-port".

• Brand Name: BD Q-SYTE 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: 13423579
• Report Number: 9610847-2022-00038
• Device Sequence Number: 11750458
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 04/04/2022

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: 03/31/2026
• Device Model Number: 385101
• Device Catalogue Number: 385101
• Device Lot Number: 1082694
• 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: 01/17/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 04/04/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/31/2022; 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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