MAUDE Adverse Event Report: MICRO EXT SET W/1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010983
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
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 when using the micro ext set w/1 ss vlv, the device experienced an occluded, clogged or blocked product.This event occurred eight times.The following information was provided by the initial reporter.The customer stated: bd identified issues with valve of the needle-free connector resulting in difficulty to flush or flow, with partial or total occlusions on extension sets with needle-free connectors.
Event or Problem Description
It was reported when using the micro ext set w/1 ss vlv, the device experienced an occluded, clogged or blocked product.This event occurred eight times.The following information was provided by the initial reporter.The customer stated: bd identified issues with valve of the needle-free connector resulting in difficulty to flush or flow, with partial or total occlusions on extension sets with needle-free connectors.
Additional Manufacturer Narrative
H6: investigation summary.No product or photo was returned by the customer.It was reported that the smartsite will not flush or flow, with partial or total occlusions.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 10010983 lot number 20055745 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29may2020.There were no 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.

• Brand Name: MICRO EXT SET W/1 SS VLV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12405170
• Report Number: 9616066-2021-51933
• Device Sequence Number: 14749980
• Product Code: FPA
• UDI-Device Identifier: 50885403233577
• UDI-Public: 50885403233577
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 05/29/2023
• Device Model Number: 10010983
• Device Catalogue Number: 10010983
• Device Lot Number: 20055745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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