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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AS LVP 20D 3SS CV BV; INTRAVASCULAR ADMINISTRATION SET
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AS LVP 20D 3SS CV BV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 11522558
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/15/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that as lvp 20d 3ss cv bv had air in the line.The following information was provided by the initial reporter: it was reported that they had an event with the air passing the ball valve and failure to/difficult to prime.
 
Event Description
It was reported that as lvp 20d 3ss cv bv had air in the line.The following information was provided by the initial reporter: it was reported that they had an event with the air passing the ball valve and failure to/difficult to prime.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 5/26/2021.H.6.Investigation: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Set was primed with saline and allowed to free flow.The iv bag was drained and air was seen getting sucked in when the water level dropped below the blue ball in the drip chamber.A notification was sent to the supplier quality expert.They were unable to duplicate the customer issue that they had an event with the air passing the ball valve and failure to/difficult to prime.The drip chamber was within spec.The root cause could not be determined because the supplier quality expert could not be replicate the issue.A device history record review could not be performed because a lot number was not provided by the customer.H3 other text : see h.10.
 
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Brand Name
AS LVP 20D 3SS CV BV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12021778
MDR Text Key257512715
Report Number9616066-2021-51340
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403232303
UDI-Public50885403232303
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/27/2021
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 Other
Device Model Number11522558
Device Catalogue Number11522558
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Initial Date Manufacturer Received 05/19/2021
Initial Date FDA Received06/17/2021
Supplement Dates Manufacturer Received09/27/2021
Supplement Dates FDA Received10/21/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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