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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS - FLOW STOP; INTRAVASCULAR ADMINISTRATION SET

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ST PAUL CADD CASSETTE RESERVOIRS - FLOW STOP; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-7302-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
Information was received regarding a cadd cassette reservoir.It was reported that during the use of the product, leakage of medical fluid within the cassette was observed.There was no patient, or clinician injury associated with this occurrence.No further details provided at this time.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms # (b)(4).No problems or issues were identified during the device history record review.One sample was received without the original opened packaging, decontaminated a connected to an extension set, without blue clip, without white cap and inside in a plastic bag.During the functional testing, a leak was detected, the sample unit presented a leak in the join with the tube of the bag, therefore the complaint was confirmed.The root cause was due to manufacturing equipment failure and the procedure not being followed.A corrective and preventative action has been opened to address the reported issue.
 
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Brand Name
CADD CASSETTE RESERVOIRS - FLOW STOP
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
7-15-26 fukushima,
minneapolis, MN 55442
MDR Report Key12698566
MDR Text Key278390981
Report Number3012307300-2021-10251
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/02/2023
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 Health Professional
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/28/2021
Initial Date FDA Received10/26/2021
Supplement Dates Manufacturer Received09/28/2021
Supplement Dates FDA Received05/01/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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