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 Leak/Splash (1354)

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

Event Date 12/06/2018

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 that leakage occurred from the bd q-syte¿ luer access split-septum stand-alone device.

Manufacturer Narrative

Investigation summary: dhr- 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 there was one non-related qn initiated during the build of this lot number 8142530 that would not impact the outcome of the quality of the product relevant to the defect stated in the pir.Received one dispenser with the catalog number 385100, lot number 8148621.Inside of the dispenser were 32 unused q-syte units in sealed packages.Visual/microscopic evaluation: no physical/mechanical damage was observed on any of the external areas of the q-syte units water leak test: the q-syte units were leak test in the actuated and unactuated position; by themselves and attached to the returned extension sets.Leakage was not confirmed in the un-actuate or actuated position during testing.Septum column tear assessment: no damage (cuts/tears) was observed along the column wall.Indeterminate: the defect leakage; could not be identified or confirmed, and cause could not be determined with the representative units returned for investigation.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in this report.

Event Description

It was reported that leakage occurred from the bd q-syte¿ luer access split-septum stand-alone device.

• 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: 8197777
• MDR Text Key: 131480587
• Report Number: 9610847-2018-00440
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 385100
• Device Lot Number: 8148621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other