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

Catalog Number 385102

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/06/2022

Event Type  malfunction  

Event Description

It was reported that the bd q-syte¿ micro bore extension set was damaged and leaked blood from between the extension tube and connector during the transfusion.This occurred 6 separate times during use.The following information was provided by the initial reporter, translated from chinese: "the head nurse of the pediatric department of the hospital gave feedback to nurses in the department of pediatrics in (b)(6) 2022, when the indwelling needle was connected to q-syte and connected to transfusion, they found blood leakage at the junction between the extension tube and the connector, which led to the need for replacement and even occupational exposure.".

Manufacturer Narrative

Initial reporter phone#: unknown.Initial reporter e-mail: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD Q-SYTE¿ MICRO BORE EXTENSION SET
• Type of Device: 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: 15499104
• MDR Text Key: 306333795
• Report Number: 9610847-2022-00373
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851027
• UDI-Public: (01)00382903851027
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 385102
• Device Lot Number: 1179966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1