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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC. TUN-L-XL; RACZ CATHETER

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EPIMED INTERNATIONAL, INC. TUN-L-XL; RACZ CATHETER Back to Search Results
Model Number 155-2540
Device Problems Physical Resistance (2578); Positioning Problem (3009)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/13/2015
Event Type  malfunction  
Event Description
On (b)(6) 2015, epimed's quality assurance department was notified of an event that had recently occurred involving an epimed tun-l-xl catheter, (catalog # 155-2540).The customer reported, "when removing the catheter, physician was feeling resistance.After removing the catheter, it did not have the fep tube of about 13 cm length from distal tip.It might be remaining in the patient's body." to date, according to epimed's knowledge of the situation, the patient has not undergone any further surgery to remove the fep coating that remains in situ within the patient.The account has been informed to notify epimed if they remove the fep coating remnant.
 
Manufacturer Narrative
Device evaluation: on (b)(6) 2015, the complaint was reviewed.At this point in time the device was not yet returned; however, the supplier provided pictures and a video of the catheter in question for epimed's review.On (b)(6)2015, the catheter in question arrived at epimed's facility for physical review.Epimed's quality assurance department examined the catheter and the corresponding (rx) needle.The rx needle did not show any signs of abuse, i.E.Being bent or etc.Next, the catheter was closely examined using 7x magnification.While inspecting the tun-l-xl catheter, it was confirmed that there was approximately 13.6 cm of the catheter's (fep) teflon outer coating unaccounted for.The angle at which the catheter was sheared (proximal to distal), indicates that the corresponding rx needle most likely remained inserted within the patient during catheter withdraw; epimed warns against this practice within their ifu pi-004.Also, while reviewing the catheter, a skive approximately 0.5 cm in length was observed on the catheter's pet inner coating.This skive occurred approximately 14.5 cm from the catheter's distal end and exposed the internal spring beneath; however, the catheter's spring remained fully intact.Epimed has confidence that if the ifu pi-004 rev.4 (spring guide epidural catheter product) was adhered to, damage to the catheter could have been prevented.
 
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Brand Name
TUN-L-XL
Type of Device
RACZ CATHETER
Manufacturer (Section D)
EPIMED INTERNATIONAL, INC.
141 sal landrio dr.
johnstown NY 12095
Manufacturer Contact
141 sal landrio dr.
johnstown, NY 12095
5187250209
MDR Report Key4798351
MDR Text Key5880048
Report Number1316297-2015-00001
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
954584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 05/13/2015
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 Health Professional
Device Expiration Date06/30/2018
Device Model Number155-2540
Device Catalogue Number155-2540
Device Lot Number11405868
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/13/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/13/2015
Initial Date FDA Received05/26/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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