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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 ACL10AT
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2017
Event Type  malfunction  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a portex® single shot epidural tray had long hairs found in the tray inside the wrap upon opening.No patient injury was reported.See mfr: 3012307300-2017-00903, 3012307300-2017-00904, and 3012307300-2017-00906.
 
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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 north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
10 bowman drive
keene NH 03431 0724
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6491541
MDR Text Key72808582
Report Number3012307300-2017-00905
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier20351688076134
UDI-Public20351688076134
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K965017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2019
Device Catalogue NumberACL10AT
Device Lot Number3311323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2016
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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