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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL SMITHS YELLOW-STRIPE ADMINISTRATION SET

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SMITHS MEDICAL SMITHS YELLOW-STRIPE ADMINISTRATION SET Back to Search Results
Model Number 21-7339-24
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2017
Event Type  malfunction  
Event Description
Major issue - big typo. Package was two filter sizes in small print at top (0. 2) and large print on pic (2. 0). Other issues - terrible labeling system, sticker on back. There are no identifiers as yellow stripe on the front of pkg (product code or words. ) there is no reference (in words) to yellow stripe anywhere. There is no yellow stripe or yellow paper. Product code is only on the reverse via sticker. We reported this to smiths (b)(4) and us on (b)(6), smiths ((b)(4)) quality systems assigned smiths complaint number (b)(4) that day. Smiths (b)(4) worked hard to quickly replace the stock, although i believe they were hampered by a decision (us) not to air ship the replacement stock in, as requested. We find smiths (b)(4) quality/business staff to be efficient, effective, open and pleasant with complaint and adverse event intake and closing communications. However, the actual investigations in-between, on device we have reported and submitted, that take place in the us or (b)(6), are non-transparent and slow (at times slower than regulations allow), we've even had files closed without investigations, even when we had submitted multiple reports and physical samples. We would be much less dissatisfied if smiths usa/(b)(6) quality was open and transparent, communicated with us about their device investigations as our other vendors do.
 
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Brand NameSMITHS YELLOW-STRIPE ADMINISTRATION SET
Type of DeviceSMITHS YELLOW-STRIPE ADMINISTRATION SET
Manufacturer (Section D)
SMITHS MEDICAL
minneapolis MN
MDR Report Key6409065
MDR Text Key70264573
Report NumberMW5068459
Device Sequence Number1
Product Code FPA
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7339-24
Device Lot Number46X831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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