MAUDE Adverse Event Report: EXT SET DEHP FREE 1SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010912
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported ext set dehp free 1ss had flow issues.The following information was provided by the initial reporter: "smartsite extension set not flushing properly.".
Event or Problem Description
It was reported ext set dehp free 1ss had flow issues.The following information was provided by the initial reporter: "smartsite extension set not flushing properly.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported that the smartsite extension set not flushing properly.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 10010912 lot number 21039510 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04mar2021.There was one quality notifications issued for the failure mode reported by the customer during the production build of this set.A definitive root cause for the customer's experience could not be determined as no needle-free connector (smartsite) was returned.Following a small number of similar reports, bd has conducted an in-depth investigation to identify any potential contributing factors for occlusion of this nature.Capa 1998036 has been initiated.The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston during the assembly process.Fluorosilicone is a lubricant used to ensure proper functioning of the needle-free connector when activated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: EXT SET DEHP FREE 1SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12363322
• Report Number: 9616066-2021-51881
• Device Sequence Number: 14539391
• Product Code: FPA
• UDI-Device Identifier: 50885403233539
• UDI-Public: 50885403233539
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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
• Operator of Device: Other
• Device Expiration Date: 03/03/2024
• Device Model Number: 10010912
• Device Catalogue Number: 10010912
• Device Lot Number: 21039510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1