MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385100

Device Problem Material Rupture (1546)

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

Event Date 03/02/2022

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 separator membrane ruptured and leaked while using the bd q-syte¿ luer access split-septum stand-alone device.The following information was provided by the initial reporter, translated from chinese to english: the head nurse of the neonatal department reported the leakage of the separator membrane joint and the rupture of the separator membrane at the negative end during the use of q-syte.

Manufacturer Narrative

Follow up mdr for device evaluation.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.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.We appreciate you taking the time to bring this observation to our attention.We regret any inconveniences this incident may have caused you and your facility.

Event Description

No additional information.

• Brand Name: BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13773518
• MDR Text Key: 287432121
• Report Number: 9610847-2022-00099
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851004
• UDI-Public: 30382903851004
• 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: 06/17/2024

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: Health Professional
• Device Model Number: 385100
• Device Catalogue Number: 385100
• Device Lot Number: 0300678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 06/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2020
• 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