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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. TUN-L-XL; CATHETER
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EPIMED INTERNATIONAL INC. TUN-L-XL; CATHETER Back to Search Results
Model Number A-NE-046
Device Problems Device Issue (2379); Device Damaged by Another Device (2915); Device Handling Problem (3265)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2017, epimed received a complaint from (b)(6) regarding a sheared tun-l-xl catheter.The report stated that during a procedure the physician experienced resistance while moving the catheter from one side to the other to inject.The report stated that the catheter could not be pulled back through the epidural needle.The needle and catheter were removed from the patient and two areas of damage were discovered on the catheter.Both the catheter and rk needle were returned to epimed on may 28, 2017.During examination, it was noticed that the outer coating of the catheter was skived approximately 4cm and 5cm from the catheters distal end, respectively.The catheter was examined using the ce-180 (ram optical measurement system), and it was determined that none of the catheters coating was missing from the returned device.The catheter also contained a slight bend approximately 3cm from its distal end.Epimed determined that this bend was placed by the physician for placement of the device prior to insertion.With both areas of skived catheter, the skive tracked from the proximal end to the distal end of the catheter.This is indicative of the catheter being withdrawn while the needle was still in place; i.E.The catheter caught on the heel of the needle's bevel/tip.The account stated that the catheter could not be pulled back through the epidural needle and that the resistance reportedly occurred while the catheter was being moved from one side to the other to inject.Epimed does allow for slight retraction of its racz catheter's within its ifu pi-004 rev.3 (spring guide epidural catheters) under warnings, which states: "9.During placement, if repositioning of catheter is necessary use extreme caution." also within the same section it states, "2.Do not remove catheter while needle is in place.Spring guide catheter and epidural needle must be removed together as a unit to prevent potential catheter damage.Although the device malfunctioned during use, the account stated that nothing was left behind in the patient, and that a new catheter and needle were used to continue the procedure.
 
Event Description
On (b)(6) 2017, epimed received a complaint from (b)(6) regarding a sheared tun-l-xl catheter.The report stated that during a procedure the physician experienced resistance while moving the catheter from one side to the other to inject.The report stated that the catheter could not be pulled back through the epidural needle.The needle and catheter were removed from the patient and two areas of damage were discovered on the catheter.
 
Manufacturer Narrative
After further review of the device, it was evident that the catheter coating was not skived, but sheared approximately 5cm from the catheters distal end.The coating appeared to have moved down the catheter tracking from the catheter's proximal end towards the distal end, with the excess coating accumulating approximately 4cm from the catheter's distal end.Epimed still concludes that the damage to the device was caused by the reporting account not properly following epimed's ifu.
 
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Brand Name
TUN-L-XL
Type of Device
CATHETER
Manufacturer (Section D)
EPIMED INTERNATIONAL INC.
141 sal landrio drive
johnstown NY 12095
Manufacturer (Section G)
EPIMED INTERNATIONAL INC.
141 sal landrio drive
johnstown NY 12095
Manufacturer Contact
kris knapp
141 sal landrio drive
johnstown, NY 12095
MDR Report Key6645238
MDR Text Key77829929
Report Number1316297-2017-00006
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K954584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date05/01/2021
Device Model NumberA-NE-046
Device Catalogue Number181-2542
Device Lot Number31427996
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/15/2017
Initial Date FDA Received06/15/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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