MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported with the use of the bd q-syte¿ luer access split-septum stand-alone device there was an issue with leakage of liquid on the side of the connector during use.

Event Description

It was reported with the use of the bd q-syte¿ luer access split-septum stand-alone device there was an issue with leakage of liquid on the side of the connector during use.

Manufacturer Narrative

H.6.Investigation: review of dhr¿s revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated.Received one used q-syte unit from catalog number 385100, lot number 7327640.Visual/microscopic evaluation: the q-syte top body displayed excessive damage (cracking) around the neck of the top body water leak test the q-syte unit was leak test in the actuated and unactuated position o leakage was confirmed in the un-actuate and actuated position during testing the defect leakage was confirmed.The source of the leakage was from the cracked polycarbonate.A definite source that contributed to this damage could not be established.Prolonged contact with cleaning solutions or incompatible medications could contribute to this type of damage.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• 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
• MDR Report Key: 8199701
• MDR Text Key: 131617585
• Report Number: 9610847-2018-00437
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• Combination Product (y/n): N
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 385100
• Device Lot Number: 7327640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other