MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE; INTRAVASCULAR ADMINISTRATION SET

Model Number 385102

Device Problem Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 7 q-syte ext set, luer-lok 6 in micro bore leaked during use.The following was reported by the initial reporter: "product leakage the gauze wrapped the connector, and when gauze was removed, it was found that there was leakage of fluid from the septation membrane.Leakage was found during the flushing tubing operation.Claims are required, the original product has been discarded and unused products of the same batch number can be mailed back to the company for investigation".

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.

Event Description

It was reported that 7 q-syte ext set, luer-lok 6 in micro bore leaked during use.The following was reported by the initial reporter: "product leakage 1.The gauze wrapped the connector, and when gauze was removed, it was found that there was leakage of fluid from the septation membrane 2.Leakage was found during the flushing tubing operation claims are required, the original product has been discarded and unused products of the same batch number can be mailed back to the company for investigation.".

• Brand Name: Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11159731
• MDR Text Key: 227077728
• Report Number: 1710034-2021-00019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30382903851028
• UDI-Public: 30382903851028
• 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: 05/17/2021

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: 385102
• Device Catalogue Number: 385102
• Device Lot Number: 0087072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1