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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX PAIN MANAGEMENT PREP TRAY; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD, INC. PORTEX PAIN MANAGEMENT PREP TRAY; ANESTHESIA CONDUCTION KIT Back to Search Results
Device Problems Break (1069); Fluid/Blood Leak (1250); Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
Event Type  malfunction  
Manufacturer Narrative
Possible catalog number contains: epx1404 /100jp.Foreign report source: (b)(6).Device evaluation: one epifuse connector was returned to smiths medical for investigation.Upon immediate visual inspection of the connector, it was confirmed that the hinge was damaged.The hinge damage confirms the reported complaint allegation.The evaluation noted the problem source of the event as the supplier.
 
Event Description
Information was received that a smiths medical portex pain management prep tray was in use when the epifuse connector broke.Therefore, medical fluid leaked from inside the connector.There were no adverse patient effects.
 
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Brand Name
PORTEX PAIN MANAGEMENT PREP TRAY
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9460634
MDR Text Key176553762
Report Number3012307300-2019-06659
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received12/12/2019
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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