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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
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/17/2017
Type of Reportable Event Malfunction
Additional 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 or Problem 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
Common Device Name
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6491541
Report Number3012307300-2017-00905
Device Sequence Number18985670
Product Code CAZ
UDI-Device Identifier20351688076134
UDI-Public20351688076134
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K965017
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,consum
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/13/2017
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
Operator of Device Health Professional
Device Expiration Date05/31/2019
Device Catalogue NumberACL10AT
Device Lot Number3311323
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/17/2017
Initial Report FDA Received Date04/13/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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