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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LOGICAL KIT; PRESSURE MONITORING

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SMITHS MEDICAL ASD, INC. MEDEX LOGICAL KIT; PRESSURE MONITORING Back to Search Results
Catalog Number DPS564928
Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 06/30/2022
Event Type  Injury  
Event Description
It was reported that the connecting screw between the red 3-way stopcock and the blue 3-way stopcock loosens again by itself during operation.This is first noticeable by falling blood pressure values, only late then the measurement stops completely.Then, of course, the puddle formation on the floor is noticeable.Additionally it was reported that disconnection was at a connection point without external influence.
 
Manufacturer Narrative
A review of the device history records revealed no observations recorded during manufacture to suggest an issue of this nature would occur with these lots of product; all inspections were completed and no issues were noted during manufacture.E4 is unknown.
 
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Brand Name
MEDEX LOGICAL KIT
Type of Device
PRESSURE MONITORING
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
NULL
201 west queen st.
southington CT 06489
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key15164438
MDR Text Key297240813
Report Number3012307300-2022-14672
Device Sequence Number1
Product Code DPT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K942377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDPS564928
Device Lot Number4245650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received08/04/2022
Supplement Dates Manufacturer Received09/23/2022
Supplement Dates FDA Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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