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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® SINGLE SHOT EPIDURAL TRAYS; ANESTHESIA CONDUCTION KIT
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SMITHS MEDICAL ASD; INC. PORTEX® SINGLE SHOT EPIDURAL TRAYS; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ACL5SPG
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2018
Event Type  malfunction  
Event Description
Information was received indicating that the 10ml syringe to a smiths medical portex® single shot epidural tray was reported to be cracked down the side leading to medication leak.It was reported that following drawing up the medication into the syringe, the medication leaked all over the physician and patient.There were no reported adverse effects.
 
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Brand Name
PORTEX® SINGLE SHOT EPIDURAL TRAYS
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key8010924
MDR Text Key125200829
Report Number3012307300-2018-01997
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E332605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberACL5SPG
Was Device Available for Evaluation? No
Date Manufacturer Received09/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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