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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. IV START KIT MICRO; KIT, IV START
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MEDLINE INDUSTRIES INC. IV START KIT MICRO; KIT, IV START Back to Search Results
Catalog Number DYND1905A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2019
Event Type  malfunction  
Event Description
While preparing for an iv, the rn retrieved an iv start kit.While inspecting the package for tears and holes the rn noticed a long strand of hair in the sealed and sterile package.The package was removed from the patient bed and sequestered for biomedical reporting.Bme confirmed the strand of hair and held on to the package for reporting to the manufacturer.The sterile package contained an iv start kit containing the following: antiseptic applicator, barrier film wipe, dressing, extension set small bore, 2x2 gauze, 10ml saline syringe, tourniquet, and transport tape.Manufacturer response for iv start kit micro, (brand not provided) (per site reporter).Mfg supplied incident # and request photo image.
 
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Brand Name
IV START KIT MICRO
Type of Device
KIT, IV START
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
MDR Report Key8739078
MDR Text Key149345407
Report Number8739078
Device Sequence Number1
Product Code LRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberDYND1905A
Device Lot Number19DBL769
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2019
Event Location Hospital
Date Report to Manufacturer06/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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