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 07/29/2021

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 the bd q-syte" luer access split-septum stand-alone device had tears around the silicone seal after sterilization.The following information was provided by the initial reporter: "reported there are tears around the silicone seal after sterilization, no patient involvement.".

Event Description

It was reported that the bd q-syte¿ luer access split-septum stand-alone device had tears around the silicone seal after sterilization.The following information was provided by the initial reporter: "reported there are tears around the silicone seal after sterilization, no patient involvement.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/27/2021.H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received fourteen units without packaging and five photos from an internal investigation.Visual inspection of the returned samples found that all units had the top disk detached from the q-syte top body.Based on the provided internal investigation, all of the returned units were detached using a scalpel.All units were tested for leakage in both the actuated and unactuated positions.Testing found that none of the units leaked in either position, likely indicating that no column tears were present on the units.Further inspection was performed by checking for column defects and no column defects were identified.The units were then dissected and microscopic inspection was performed.There was evidence of cured adhesive around the rim of the fourteen q-sytes, indicating that the septum top disk had been properly adhered to the q-syte during manufacturing.All 14 units showed evidence of a material residue running along the length of the inside of the top body where the column of the septum meets the top body inner wall, an occurrence know as wicking.One of the units had the column still adhered to the inner wall of the top body, confirming that the material residue observed on the other units was most likely adhesive.Although none of the units had tears that went through the septum material, all units exhibited thinning of the wall material.The location of the thinning coincided with the location of the adhesive which likely indicated that detachment of the column from the adhesive may have happened postproduction, likely during the internal investigation.On all 14 units there was evidence of additional column damage directly underneath the top disk and running parallel to the top disk although this may have been caused by the scalpel or by stretching the material using tweezers as both instruments were indicated to have been used during the internal investigation to detach the top disk from the top body.Based this investigation, bd was able to confirm the occurrence of adhesive wicking which is related to the manufacturing process.Bd was unable to confirm any leakage.The septum is designed to minimize wicking of the adhesive down the column; however, this type of defect may still occur and may potentially result in leakage when exacerbated by excessive actuations.Although wicking was confirmed in the fourteen returned units, no leakage was observed.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12374144
• MDR Text Key: 268362826
• Report Number: 9610847-2021-00400
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 0119940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• 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