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

Catalog Number 385156

Device Problems Insufficient Flow or Under Infusion (2182); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved. The information for each additional lot number is as follows: medical device lot #: 0036706. Medical device expiration date: 31jan2023. Device manufacture date: 09mar2020. A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd q-syte¿ macrobore tri-extension the tubing was kinked. This occurred twice. There was no report of patient impact. The following information was provided by the initial reporter: kinked tubing received, that hampering flow rate of infusion.

• Brand Name: BD Q-SYTE¿ MACROBORE TRI-EXTENSION
• 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: 14794364
• Report Number: 9610847-2022-00234
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K142527
• 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,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 385156
• Device Lot Number: 0121418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG