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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KENDAL SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH
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COVIDIEN KENDAL SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Lot Number 13K2734
Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 04/04/2014
Event Type  malfunction  
Event Description
Individual package of saline flush was pulled from supply.When saline flush was opened, a black substance was noted in the tip of the syringe and the cap.Also noted black particles floating in syringe.The entire stock with this lot number was immediately pulled from the supply area.All product with this lot number were given to the supply chain analyst and will be returned to the manufacturer.
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manufacturer response for saline flush, (brand not provided) (per site reporter).
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local kendall rep contacted and arranged for saline flush and lot numbers from same packaging in question were picked up on (b)(4) 2014.Unknown as to any feedback from them at this point.Supply chain analyst involved.
 
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Brand Name
KENDAL SALINE FLUSH
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
COVIDIEN
15 hampshire st
mansfield MA 02048
MDR Report Key3763208
MDR Text Key20325550
Report Number3763208
Device Sequence Number1
Product Code NGT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/18/2014
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
Device Operator Invalid Data
Device Lot Number13K2734
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2014
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2014
Event Location Hospital
Date Report to Manufacturer04/22/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2014
Patient Sequence Number1
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