MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE¿ BI-EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385161
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set broke during use.The following information was provided by the initial reporter, translated from spanish: "the bioconnector breaks when used, without misuse of it.".
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set broke during use.The following information was provided by the initial reporter, translated from spanish: "the bioconnector breaks when used, without misuse of it.".
Additional Manufacturer Narrative
Additional information h6: imdrf annex a grid: a0504.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of component damage was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
Event or Problem Description
It was reported that the bd q-syte¿ bi-extension set broke during use.The following information was provided by the initial reporter, translated from spanish: "the bioconnector breaks when used, without misuse of it.".

• Brand Name: BD Q-SYTE¿ BI-EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15802018
• Report Number: 1710034-2022-00700
• Device Sequence Number: 14868017
• Product Code: FPA
• UDI-Device Identifier: 00382903851614
• UDI-Public: (01)00382903851614
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2022

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: 05/31/2023
• Device Catalogue Number: 385161
• Device Lot Number: 0162610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 11/24/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/22/2022; 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2020
• 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