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 Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd q-syte¿ needle-free connector leaked.The following information was provided by the initial reporter, translated from mandarin chinese to english: there is air leak in the tube.
Additional Manufacturer Narrative
Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 11-jan-2023.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issues of flow issues - fluid blockage and component damage ¿ leak were not confirmed upon inspection and testing of the sample.Analysis of the sample showed that the sample was incomplete and was missing the q-syte component.The incomplete sample was put through our internal leakage testing and the sample showed no signs of leakage.Since the defects were not confirmed a root cause could not be identified.
Event or Problem Description
It was reported that the bd q-syte¿ needle-free connector leaked.The following information was provided by the initial reporter, translated from mandarin chinese to english: there is air leak in the tube.

• 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: 15929421
• Report Number: 9610847-2022-00458
• Device Sequence Number: 11861461
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: (01)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): 02/01/2023

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: Other
• Device Model Number: 385101
• Device Catalogue Number: 385101
• Device Lot Number: UNKNOWN
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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