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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. TUN-L-XL/24
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EPIMED INTERNATIONAL INC. TUN-L-XL/24 Back to Search Results
Model Number A-EP-089
Device Problems Retraction Problem (1536); Human Factors Issue (2948); Device Handling Problem (3265)
Patient Problem No Information (3190)
Event Date 03/01/2017
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2017, dr.(b)(6), physician at (b)(6), reported that he had a broken catheter.No other information was provided by the account.On march 30, 2017, the product arrived at (b)(4) facility for examination.The reporting account returned approximately 16.5cm of the catheter.This fragment was from the distal end of the catheter tracking 16.5cm towards the catheter's proximal end.The shear appeared to track slightly from the catheter's proximal end to the catheter's distal end.This is indicative of the account retracting the catheter while the needle was still in place.On april 6, (b)(4) emailed (b)(4), their (b)(4) sales consultant, in an attempt to gain more information regarding the reported event.As of april 10, no additional information had been provided.The complaint report stated that no patient information is provided by doctors or nurses in (b)(4) due to privacy data protection laws.Based on the portion of the catheter that was returned to (b)(4) , it is believed that none of the catheter was retained within the patient.Batch history records were reviewed for any anomalies within the lot; however, none were found.(b)(4) will continue to follow up with (b)(4) in order to gain additional information.This report will be updated once new information becomes available.
 
Event Description
On (b)(6) 2017, dr.(b)(6), physician at (b)(6), reported that he had a broken catheter.No other information was provided by the account.On march 30, 2017, the product arrived at (b)(4) facility for examination.The reporting account returned approximately 16.5cm of the catheter.This fragment was from the distal end of the catheter tracking 16.5cm towards the catheter's proximal end.The shear appeared to track slightly from the catheter's proximal end to the catheter's distal end.This is indicative of the account retracting the catheter while the needle was still in place.On april 6, (b)(4) emailed (b)(4), their (b)(4) sales consultant, in an attempt to gain more information regarding the reported event.As of april 10, no additional information had been provided.The complaint report stated that no patient information is provided by doctors or nurses in (b)(4) due to privacy data protection laws.Based on the portion of the catheter that was returned to (b)(4) , it is believed that none of the catheter was retained within the patient.Batch history records were reviewed for any anomalies within the lot; however, none were found.(b)(4) will continue to follow up with (b)(4) in order to gain additional information.This report will be updated once new information becomes available.
 
Manufacturer Narrative
Epimed sent a second email to the account representative on april 24, 2017, in an effort to acquire additional information regarding the reported complaint.The account representative responded on april 25, 2017, stating that there was no new information to report from the account in question.
 
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Brand Name
TUN-L-XL/24
Type of Device
TUN-L-XL/24
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
5187250207
MDR Report Key6476930
MDR Text Key72500306
Report Number1316297-2017-00001
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K954584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/10/2017
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 Physician
Device Expiration Date06/01/2021
Device Model NumberA-EP-089
Device Catalogue Number155-2542
Device Lot Number11427578
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/30/2017
Initial Date FDA Received04/10/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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