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

Model Number 385100

Device Problem Leak/Splash (1354)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the septum of the bd q-syte¿ luer access split-septum stand-alone device came unglued and was drawn into the body.The following information was provided by the initial reporter: "some of split septum was drawn into body".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 12/3/2020 h.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two photographs displaying two different views of a q-syte unit without packaging with septum pushed into the top body of the q-syte.In addition, one used unit was received which revealed similarities to that of the provided photos.Upon microscopic evaluation of the unit, it is confirmed that there are residual septum material and adhesive deposits on the rim of the top body (polycarbonate) and top disk, which indicate a sufficient bond at the time of manufacture.There were no signs of a column wall tear.A water leak test was performed where leakage was observed in the unactuated position at the top slit.This leak is likely due to the damage observed to the septum.Although the reported issue was confirmed, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.See h.10.

Event Description

It was reported that the septum of the bd q-syte¿ luer access split-septum stand-alone device came unglued and was drawn into the body.The following information was provided by the initial reporter: "some of split septum was drawn into body".

• 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: 10997409
• MDR Text Key: 221234585
• Report Number: 9610847-2020-00410
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other