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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
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SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) Back to Search Results
Catalog Number 100/860/080
Device Problems Manufacturing, Packaging or Shipping Problem (2975); Inaccurate Information (4051)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
It was reported that the user opened the package and determined the device was a size 8.5 device while the device labeling indicated size 8.0.No patient involvement reported; device not used.
 
Manufacturer Narrative
One portex blue line ultra tracheostomy (trach) tube was returned for analysis in used condition.Upon visual inspection, the sample was observed to be an 8.0 flange with a printed inflation line of 8.5.Relevant documents were reviewed and deemed adequate.The manufacturing process was reviewed.The following operations were reviewed and deemed adequate with no discrepancies; line clearance records, training records, inflation line assembly operation.Visual inspection of 32 units were performed prior to packaging finding no discrepancies.Based on the evidence, the complaint is confirmed and the root cause is due to manufacturing.
 
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Brand Name
PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis MN 55442
MDR Report Key7873036
MDR Text Key120244655
Report Number3012307300-2018-03883
Device Sequence Number1
Product Code BTO
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 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number100/860/080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2018
Date Manufacturer Received10/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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