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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX DEK BL MF 0 DLX40 1N 75CM; SUTURE
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TELEFLEX DEK BL MF 0 DLX40 1N 75CM; SUTURE Back to Search Results
Catalog Number ED-6276
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2014
Event Type  malfunction  
Event Description
Complaint alleges: it was reported that "the suture tears easily, during knotting." no reported pt injury.
 
Manufacturer Narrative
The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No rejection report were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our inspections.No corrective actions can be implanted due the lack of product sample to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and to determine the root cause.However, the manufacturer will continue to trend relating complaints.
 
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Brand Name
DEK BL MF 0 DLX40 1N 75CM
Type of Device
SUTURE
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer (Section G)
TELEFLEX
Manufacturer Contact
jasmine brown
po box 12600
durham, NC 27709
9193614124
MDR Report Key3950620
MDR Text Key4603428
Report Number3004365956-2014-00208
Device Sequence Number1
Product Code GAL
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberED-6276
Device Lot Number02E1302607
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
Is the Device Single Use? Yes
Patient Sequence Number1
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