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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMALLBORE 6 INCH EXT VLV, 7 DAY INTRAVASCULAR ADMINISTRATION SET

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SMALLBORE 6 INCH EXT VLV, 7 DAY INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 20039E7D
Device Problems Complete Blockage (1094); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: seven 20039e7d samples were received in open packaging for investigation; two from lot 20125582 and five from lot 21055717. The connecting product in use at the time of the customer's experience was not returned to assist the investigation. A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience. Functional testing was performed by connecting a retained 50ml bd plastipak syringe from stock to each of the returned samples; in each instance no flow restrictions or occlusions were identified. The details of this feedback were forwarded to the manufacturing site for investigation. A review of the production records for lot 20125582 and 21055717 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. A definitive root cause for the customer's experience could not be determined as no occlusion or flow restriction was observed during testing of the returned smartsite. 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. Due to previous similar reports of this nature bd is currently recommending when encountering needle-free connector flow issues the following: depress the syringe plunger while the syringe is still attached to the needle free connector. If unable to depress the plunger, pull back on the syringe plunger and depress the syringe plunger again. Repeating this step may assist in opening the needle-free connector valve. 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 20039e7d set in the past 12 months.
 
Event Description
It was reported that smallbore 6 inch ext vlv, 7 day was clogged. The following information was provided by the initial reporter: "during set up for iv insertion, extension sets have attempted to be primed with normal saline. Unable to prime sets. ".
 
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Brand NameSMALLBORE 6 INCH EXT VLV, 7 DAY
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
MDR Report Key12694376
MDR Text Key278361944
Report Number9616066-2021-52306
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number20039E7D
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/08/2021
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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