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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. NEURO IR DRAPE PACK-LF; CUSTOM SURGICAL PACK
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MEDLINE INDUSTRIES, INC. NEURO IR DRAPE PACK-LF; CUSTOM SURGICAL PACK Back to Search Results
Catalog Number DYNJ0780244K
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2016
Event Type  malfunction  
Event Description
Flush bag was properly primed and hung by technicians at 13:19.At 16:02, physician noted air in the tubing distal to the clamp and proximal to the 3 way stopcock.No air entered the patient.The entire flush was taken down.Examination of the pressure bag/heparin flush revealed full inflation and proper heparin flush bag placement within the pressure bag.Further examination of the bag was performed after the case, flushing the air out of the line successfully and clamping the distal end of the tubing.No air was seen, but air appeared within ~ 15 seconds.This is suspicious for a micro-fracture of the tubing, allowing air to enter the tubing.Tubing came from medline neuro ir drape pack-lf, reorder no dynjo780244k, lot 161k0429.
 
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Brand Name
NEURO IR DRAPE PACK-LF
Type of Device
CUSTOM SURGICAL PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
1170 s. northpoint blvd.
waukegan IL 60085
MDR Report Key6221119
MDR Text Key63814512
Report Number6221119
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 12/21/2016,12/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberDYNJ0780244K
Device Lot Number16IK0429
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/21/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer12/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
BAXTER SOLUTION SET WAS WITHIN THIS PACK, 1C8160S,
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