MAUDE Adverse Event Report: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Material Deformation (2976)

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

Event Date 08/12/2021

Event Type  malfunction  

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.

Event Description

It was reported that the septum of the bd q-syte¿ luer access split-septum stand-alone device pushed into the adapter during use.The following information was provided by the initial reporter: "when using a q-syte connector, the membrane of the q-site moves into the actual housing of the connector, and has to be exchanged.Has happened several times earlier as well, and a previous case is reported from the same ward in june.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-09-14.H6: investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one q-syte and a miscellaneous cap.During the initial visual examination it was observed that the septum of the unit had been pushed into the top body, confirming the defect of component damage.The unit was microscopically inspected and found to have no voids in adhesive residue on the top disk and body indicating proper adhesion of the septum at the time of manufacture.No additional damage to the unit was found during the microscopic inspection.The septum may become pushed in due to excessive force exerted on the septum in the clinical environment or during the manufacturing process.Bd was unable to determine a definite root cause as both scenarios would look the same.A device history record review could not be performed as the lot number is unknown.H3 other text : see h10.

Event Description

It was reported that the septum of the bd q-syte¿ luer access split-septum stand-alone device pushed into the adapter during use.The following information was provided by the initial reporter: "when using a q-syte connector, the membrane of the q-site moves into the actual housing of the connector, and has to be exchanged.Has happened several times earlier as well, and a previous case is reported from the same ward in (b)(6).".

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12447815
• MDR Text Key: 270587356
• Report Number: 9610847-2021-00425
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• 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: 09/14/2021
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1