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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC MERIT; PACEMAKER KIT
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MEDLINE INDUSTRIES, INC MERIT; PACEMAKER KIT Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pneumothorax (2012)
Event Date 07/16/2014
Event Type  malfunction  
Event Description
Md attempted to obtain iv access via left subclavian vein with difficulty with glidewire threading thru access needle and syringe plunger working adequately.Md stated "there is something wrong with this needle.I need a new one." post procedure when standard chest x-ray was done a 40% left pneemothorax was present.The patient was than admitted as an inpatient instead of being discharged.
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manufacturer response for vascular access needle from safe sheath and syringe from pacemaker pack, merit medical classic sheath (per site reporter)
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medline, manufacturers of the pacemaker tray, representative will be picking up syringe and a message has been left foe merit medical classic sheath sales representative.
 
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Brand Name
MERIT
Type of Device
PACEMAKER KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC
one medline place
mundelein IL 60060
MDR Report Key4091592
MDR Text Key4831643
Report Number4091592
Device Sequence Number1
Product Code LRO
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 07/18/2014
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2014
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer09/16/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SHEATH 8FR STANDARD; ASSESS NEEDLE FROM MERIT MEDICAL CLASSIC SAFE; 0.89MM) 150CM; 13CM RADIFOCUS GLIDEWIRE GR3506, 0.035; 10 ML SYRINGE 10 ML L/L
Patient Age87 YR
Patient Weight73
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