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 Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set had air bubbles in the line and leaked at the connection to the tubing.The following information was provided by the initial reporter, translated from dutch: "the nurse reported to me that bubbles were released at the connection to the pipe.Yes leakage was identified (wet= leakage!)".
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.
Additional Manufacturer Narrative
H.6.Imdrf annex g grid: g04034.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set had air bubbles in the line and leaked at the connection to the tubing.The following information was provided by the initial reporter, translated from dutch: "the nurse reported to me that bubbles were released at the connection to the pipe.Yes leakage was identified (wet= leakage!)".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes.D.10.Returned to manufacturer on: 03-aug-2022.H.6.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of air bubbles / air in line and leakage was not confirmed upon inspection and testing of the sample.The sample underwent our internal leakage testing and no signs of leakage or air within the line was observed.Bd cannot associate this failure to the manufacturing process since the failure was not observed during testing.There is a possibility that the connections were not correct during the use of the sample.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set had air bubbles in the line and leaked at the connection to the tubing.The following information was provided by the initial reporter, translated from dutch: "the nurse reported to me that bubbles were released at the connection to the pipe.Yes leakage was identified (wet= leakage)".

• 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: 15136343
• Report Number: 9610847-2022-00275
• Device Sequence Number: 5268484
• Product Code: FPA
• UDI-Device Identifier: 50382903851633
• UDI-Public: 50382903851633
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/14/2022

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: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: 385163
• Device Catalogue Number: 385163
• Device Lot Number: 1329095
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 09/14/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/08/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• 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