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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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.(b)(4).

Event Description

It was reported that the bd q-syte luer access split-septum stand-alone device experienced leakage.The following information was provided by the initial reporter: (b)(4) q-syte - the q-syte base was leakage.No photos available.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/14/2020.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used q-syte unit which consists of the q-syte only.Through the microscopic evaluation, the unit reveals traces of dried media present on the unit.There is a large tear at one end and at the center of the slit at the septum top disk along with impressions of damage around the slit.There are also large tears at each end of the slit at the septum bottom disk.A leakage test was performed where leakage was not observed from any area of the unit when tested in the unactuated and actuated positions.Although the report of leakage was not confirmed, the damage to the septum was verified.The observed defect could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing tear(s) at the top and/or bottom disk can be caused by a damaged, dull or misaligned blade during the septum slit process.Tears to the column wall can occur when the probe enters the slit due to mandrel misalignment.During use, damage to the septum, as seen in the unit, can occur due to excessive actuations and extraneous force.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported that the bd q-syte¿ luer access split-septum stand-alone device experienced leakage.The following information was provided by the initial reporter: 385100-q-syte - the q-syte¿s base was leakage.No photos available.

• 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 ; MX
• MDR Report Key: 11088800
• MDR Text Key: 226858511
• Report Number: 9610847-2020-00433
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: 00382903851003
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: 0027180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1