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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; INTERVENTION
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SMITHS MEDICAL ASD, INC. MEDEX; INTERVENTION Back to Search Results
Model Number MX693R
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2021
Event Type  malfunction  
Event Description
Information received a interventional imaging|medex high pressure tubing malfunctioned.The report indicated that on two different occasions the tubing ruptured when doing pump pressure injection during a procedure.Rated for 900psi, were using 700-800 psi.No patient injury during procedure was reported.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Conclusion: the defect reported could not be attributable to the manufacturing process, since the 46 samples passed the high pressure test and the reported lot was found within specifications during high pressure test during its manufacture.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
MEDEX
Type of Device
INTERVENTION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
MDR Report Key11685834
MDR Text Key246027443
Report Number3012307300-2021-03268
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10351688505811
UDI-Public10351688505811
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMX693R
Device Catalogue NumberMX693R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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