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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC; PORT ACCESS, KIT
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MEDICAL ACTION INDUSTRIES, INC; PORT ACCESS, KIT Back to Search Results
Catalog Number 59043C
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2014
Event Type  malfunction  
Event Description
There have been four known instances when the needle bent as the nurse was attempting to access the portacath.The needle is currently distributed by smith's medical, but was formerly deltec.The nurses described the needle as "giving way" upon entry into the port.The nurses have experience with using the needle.There was no patient harm in any of the four events.Manufacturer response for blunt cannula non coring safety needle, gripper micro (per site reporter).
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the smiths medical rep came immediately to the facility to meet with team, and assisted staff with replacement of this needle lot 34x136.This was difficult as this needle is part of a port access kit which is assembled by medical action industries, inc.These kits also had to be identified.
 
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Type of Device
PORT ACCESS, KIT
Manufacturer (Section D)
MEDICAL ACTION INDUSTRIES, INC
500 expressway drive south
brentwood NY 11717
MDR Report Key3965952
MDR Text Key19925779
Report Number3965952
Device Sequence Number1
Product Code LRS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number59043C
Device Lot Number187966
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2014
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2014
Event Location Hospital
Date Report to Manufacturer07/30/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NON-CORING SAFETY NEEDLE, CATALOG 21-3277-24,; THE PORT ACCESS KITS.; SMITH'S MEDICAL GRIPPER MICRO BLUNT CANNULA,; LOT #34X136, EXPIRATION: 02/01/2019 -THE NEEDLE IN
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