MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ NEEDLE-FREE CONNECTOR WITH 15CM (6 IN.) MACRO BORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	385101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
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.The initial reporter phone #: (b)(6).
Event or Problem Description
It was reported by the customer that during use of the bd q-syte¿ needle-free connector with 15cm (6 in.) macro bore extension set, the tube broke and leakage occurred from the broken site.The following information was provided by the initial reporter: "tube broken, and leakage from broken site.Incident occur : during use.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 22-jul-2022.H6: investigation summary : our quality engineer inspected the several samples and photos submitted for evaluation.The reported issue of component damage - leak was confirmed upon inspection of the samples.Bd cannot confirm that the cause of the failure is related to our manufacturing process since the defect could not be reproduced in our investigation.The device history records (dhr) review was performed for the lot number material identified in this complaint.
Event or Problem Description
It was reported by the customer that during use of the bd q-syte¿ needle-free connector with 15cm (6 in.) macro bore extension set, the tube broke and leakage occurred from the broken site.The following information was provided by the initial reporter: "tube broken, and leakage from broken site.Incident occur : during use".

• Brand Name: BD Q-SYTE¿ NEEDLE-FREE CONNECTOR WITH 15CM (6 IN.) MACRO BORE 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: 15008706
• Report Number: 9610847-2022-00258
• Device Sequence Number: 6819740
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/11/2022

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: 1113054
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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