MAUDE Adverse Event Report: TELEFLEX MEDICAL DEKNATEL DEK BL MF 0 TC-43 2N 48; SUTURE NEEDLE

Catalog Number 833-123

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

Alleged issue: after the surgeon had thrown and caught the suture on each side of the sacrospinous ligament, as he was pulling the suture out of the body, the taper-cut needle tip came off on both sides.The surgeon decided to leave these needle tips in the patient.No patient injury reported.

Manufacturer Narrative

(b)(4).A device history record (dhr) review could not be conducted since the lot number was not provided.No corrective actions can be established since it is necessary to retrieve the physical sample to perform a proper investigation and to confirm the defect.At this time, due to the lack of defective product, it is not possible to confirm the complaint and to determine the root cause.The manufacturer will continue to monitor and trend relating complaints.

• Brand Name: DEKNATEL DEK BL MF 0 TC-43 2N 48
• Type of Device: SUTURE NEEDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: jasmine brown, reg. affairs ; 3015 carrington mill blvd., ra; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4671628
• MDR Text Key: 5619349
• Report Number: 3004365956-2015-00123
• Device Sequence Number: 1
• Product Code: MFJ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 833-123
• Device Lot Number: 74F1401388
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1