MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 385101

Device Problem Leak/Splash (1354)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue was not confirmed upon inspection of the photo, since it did not provide sufficient evidence for leakage.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformance's associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.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.

Event Description

It was reported that 3 bd q-syte¿ extension sets leaked from their female ports during use.The following information was provided by the initial reporter: "leakage from female port, as pointed".

• Brand Name: BD Q-SYTE¿ EXTENSION SET
• 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
• MDR Report Key: 12675222
• MDR Text Key: 277899764
• Report Number: 9610847-2021-00511
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851011
• UDI-Public: 30382903851011
• Combination Product (y/n): N
• PMA/PMN Number: K142527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 385101
• Device Catalogue Number: 385101
• Device Lot Number: 0146032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2020
• 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