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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 Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that as lvp 20d 3ss cv bv was difficult to prime.The following information was provided by the initial reporter: it was reported that they are having instances of failure to/difficult to prime.
 
Event Description
It was reported that as lvp 20d 3ss cv bv was difficult to prime.The following information was provided by the initial reporter: it was reported that they are having instances of 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.The set was primed with saline.The set was successfully primed.The customer complaint that they are having instances of failure to/difficult to prime could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 11522558 lot number 20116057 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of flow issues - fluid blockage with lot #20116057 regarding item #11522558.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 Key12021776
MDR Text Key257511597
Report Number9616066-2021-51341
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
Date FDA Received06/17/2021
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 Number20116057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2020
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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