MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE CLOSED LUER ACCESS DEVICE; RAVASCULAR ADMINISTRATION SET

Catalog Number 385100

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported that bd q-syte luer access split- septum was accessed vertically and leaked.The following information was provided by the initial reporter, translated from chinese to english: the nurse followed the doctor's instructions and performed infusion treatment for the patient.After about 10 minutes of infusion, the family members discovered that there was liquid leakage from the connection between the separator membrane needleless sealed infusion connector and the infusion set.The nurse immediately dealt with it.No abnormality was found in the appearance, and the separator membrane needleless seal was replaced.Type infusion connector, no liquid leakage.Information received on december 16th 2023"after communicating with the customer, this event was caused by the customer not plugging and unplugging vertically during operation, which resulted in damage to the separation membrane.".

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 385100 and lot number 2280065.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Based on the available information, an exact cause for this incident could not be identified.As per customer verbatim, after communicating with the customer, this adverse event was caused by the customer not plugging and unplugging vertically during operation, which resulted in damage to the separation membrane.

Event Description

No additional information.

• Brand Name: BD Q-SYTE CLOSED LUER ACCESS DEVICE
• Type of Device: RAVASCULAR 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18456584
• MDR Text Key: 332211075
• Report Number: 1710034-2023-01508
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: 2280065
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1