MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD Q-SYTE LUER ACCESS SPLIT SEPTUM; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Defective Device (2588)

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

Event Date 05/04/2023

Event Type  malfunction  

Event Description

It was reported that the bd q-syte luer access split septum experienced damage of the needle-free joint.The following information was provided by the initial reporter, translated from chinese to english: the surface collapse of needle-free joint in use requires green claim and complaint reply letter.

Manufacturer Narrative

Initial reporter phone #: (b)(6).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 experienced damage of the needle-free joint.The following information was provided by the initial reporter, translated from chinese to english: the surface collapse of needle-free joint in use requires green claim and complaint reply letter.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 22-may-2023.H6: investigation summary: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used q-syte unit with no product documentation to indicate the reference or lot number.The photos are representative of what was returned and do not provide any additional evidence that isn¿t already covered by the physical sample evaluation.A gross visual inspection of the returned unit found that a portion the septum top disk was pushed in.Further inspection found that the portions of the top disk where the septum was not pushed in were still properly adhered.The unit was microscopically inspected.Inspection found that adhesive residue was present along the entire rim of the top body and on the underside of the top disk, indicating that adequate adhesion of the septum had been achieved during manufacture of the device.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.During manufacturing, low bond strength (or insufficient adhesive), septum misorientation, damage to the top body of the q-syte, and damaged tooling may result in the septum being pushed in.Operator-controlled checks for bond strength and septum damage are performed to mitigate the risk from this type of defect.Additionally, during use, a pushed in septum can occur due to excessive actuations and extraneous force.Given that the sample was returned in a used state, this scenario cannot be ruled out.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
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17014891
• MDR Text Key: 316440479
• Report Number: 1710034-2023-00576
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903851003
• UDI-Public: 00382903851003
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/02/2023

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 Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: 1293672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 07/02/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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