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

Model Number 385100

Device Problems Loose or Intermittent Connection (1371); Improper Flow or Infusion (2954)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

It was reported that while using the bd q-syte luer access split septum the connection separated and there was flow issues.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the gastroenterology department for treatment due to "gastritis".On (b)(6)2023, at 8:30 am, as instructed by the doctor, intravenous infusion was given.After using a pre flushing tube, the transparent film end of the closed infusion joint collapsed, and after connecting the infusion device, the liquid could not drip smoothly.After replacing the infusion joint with a new one, the infusion proceeded smoothly.Received an update from the sales representative, and the description of the incident was updated as follows: after communicating with the customer of the department of gastroenterology of omit hospital, it was learned that the situation occurred during the indwelling needle catheterization of the q-syte connection, and the connector had been discarded, so the cause of the situation could not be analyzed.

Manufacturer Narrative

E1.Initial reporter phone #: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that while using the bd q-syte luer access split septum the connection separated and there was flow issues.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the gastroenterology department for treatment due to "gastritis".On (b)(6) 2023, at 8:30 am, as instructed by the doctor, intravenous infusion was given.After using a pre flushing tube, the transparent film end of the closed infusion joint collapsed, and after connecting the infusion device, the liquid could not drip smoothly.After replacing the infusion joint with a new one, the infusion proceeded smoothly.Received an update from the sales representative, and the description of the incident was updated as follows: after communicating with the customer of the department of gastroenterology of omit hospital, it was learned that the situation occurred during the indwelling needle catheterization of the q-syte connection, and the connector had been discarded, so the cause of the situation could not be analyzed.

• 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: 17221797
• MDR Text Key: 318303048
• Report Number: 1710034-2023-00744
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: 1348355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• 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