MAUDE Adverse Event Report: Q-SYTE CLOSED LUER ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 385100

Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)

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

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that q-syte closed luer access device the following information was provided by the initial reporter: after the line has been inserted, generally a few tens of minutes afterwards, the nurse observes drops of the infused solution on the floor.In the very specific case of the serious incident mentioned, we also had a rise of air in the tubing.Fortunately, there were no clinical consequences in the end, the patient was placed in a hyperbaric chamber after the incident was detected, and was able to leave the hospital.

Event Description

It was reported that q-syte closed luer access device leaked.The following information was provided by the initial reporter: after the line has been inserted, generally a few tens of minutes afterwards, the nurse observes drops of the infused solution on the floor.In the very specific case of the serious incident mentioned, we also had a rise of air in the tubing.Fortunately, there were no clinical consequences in the end, the patient was placed in a hyperbaric chamber after the incident was detected, and was able to leave the hospital.

Manufacturer Narrative

The following fields were updated due to additional information: b5: describe event or problem: it was reported that q-syte closed luer access device leaked.The following information was provided by the initial reporter: after the line has been inserted, generally a few tens of minutes afterwards, the nurse observes drops of the infused solution on the floor.In the very specific case of the serious incident mentioned, we also had a rise of air in the tubing.Fortunately, there were no clinical consequences in the end, the patient was placed in a hyperbaric chamber after the incident was detected, and was able to leave the hospital.D10: device available for eval yes, d10: returned to manufacturer on: 2021-07-09.H6: investigation summary: our quality engineer inspected the sample and video submitted for evaluation.Bd received one video and one non-bd ramp with five bd q-syte devices attached.One of the q-sytes had a miscellaneous attachment.During the initial observation, the miscellaneous attachment was removed and it was noted that a portion of the attachment remained inside the slit of the top disk, actuating the q-syte septum.As the q-sytes were bonded to the ramp, all testing was conducted with the q-sytes attached to the ramp.A leak test was performed by attaching a 20ml bd iso standard luer-lock syringe to the end of the ramp.A flush was performed and flow was noted from the q-syte which had the broken miscellaneous attachment actuating the q-syte septum.This was expected as the broken attachment was actuating the septum allowing flow to occur.There was no leakage from the threads indicating that there was no insecure or incompatible connection between the threads of the attachment and q-syte.The miscellaneous attachment was removed from the q-syte.No damage was noted to the q-syte septum.The leak test was repeated without the miscellaneous attachment and no leakage was observed form any part of the q-syte.Based on the results of the leak tests and the fact that the miscellaneous attachment was broken, it was concluded that the leak was a result of the broken miscellaneous attachment and was not related to the q-syte.Since the q-syte was used with a non-bd product, bd was unable to confirm the report of incompatibility.The ifu states that the q-syte device is intended for use only with the following: intravascular line and iso luer-slip and luer-lock connectors on standard iv administration set, extension set, and syringes.A device history record review could not be performed as the lot number is unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: Q-SYTE CLOSED LUER ACCESS DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12047009
• MDR Text Key: 261231116
• Report Number: 9610847-2021-00284
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 09/03/2021
• 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
• Patient Outcome(s): Required Intervention