MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE EXTENSION SET 15 CM; INTRAVASCULAR ADMINISTRATION SET

Model Number	385101
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd q-syte extension set 15 cm was deformed.The following information was provided by the initial reporter: "hub deformation.".
Event or Problem Description
It was reported bd q-syte extension set 15 cm was deformed.The following information was provided by the initial reporter: "hub deformation".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-02.H6: investigation summary: our quality engineer inspected the photo and unpacked sample submitted for evaluation.The reported issue was confirmed upon inspection of the photo and sample.Bd can confirm the cause of the failure to be related to our packaging process where the component could have been stuck in our multivac machine, or a scrap material was accidentally packaged.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.A quality alert was generated, and all personnel involved in the process were informed of the failure.

• Brand Name: BD Q-SYTE EXTENSION SET 15 CM
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12620590
• Report Number: 9610847-2021-00497
• Device Sequence Number: 5823316
• 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
• Report Date (Section B): 11/04/2021

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: 05/31/2025
• Device Model Number: 385101
• Device Catalogue Number: 385101
• Device Lot Number: 0146032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 12/05/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2020
• 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