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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET

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SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20039E
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used as a default. Investigation summary: a 20039e sample was not available for investigation of this feedback; however the customer confirmed that the complaint sample was from lot 21065302. The customer indicates that an occlusion was identified during priming with an unknown luer lock syringe. The connecting product in use at the time of the customer's experience was not returned to assist the investigation the details of this feedback were forwarded to the manufacturing site for investigation. A review of the production records for lot 21065302 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. The root cause of the customer¿s experience could not be determined as the sample was not available for investigation. In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience. 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. The investigation has determined that a potential contributor could be the result of an insufficient amount of fluorosilicone having been injected into the piston of the smartsite during the assembly process; fluorosilicone is used as a lubricant within the smartsite to ensure the consistent opening of the piston when the smartsite is activated, and an insufficient amount may cause a temporary occlusion. Additionally previous investigations have also determined that features on the surface of the male luer of the connecting products may also contribute to occlusions of this nature. These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite and not allowing it to open. This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer. In this instance as the connecting product and affected product were not available for investigation it could not be determined which is the most likely root cause for the customer's experience in this instance. Please note, in order to minimize reports for occlusions of this nature, the manufacturing site has repaired the assembly machine to ensure that an adequate amount of fluorosilicone is injected into each smartsite. A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20039e product in the past 12 months.
 
Event Description
It was reported that smallbore 6 inch ext vlv had flow issues and was clogged. The following information was provided by the initial reporter: "can¿t priming at beginning. ".
 
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Brand NameSMALLBORE 6 INCH EXT VLV
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12454495
MDR Text Key270920243
Report Number9616066-2021-52010
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number20039E
Device Catalogue Number20039E
Device Lot Number21065302
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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