MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. PREMILENE 4/0 (1.5) 45CM DS19 (M); NON-ABSORBABLE SUTURE

Model Number C2090220

Device Problem Unraveled Material (1664)

Patient Problem Suture Abrasion (2497)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).After repeatedly pulling through the thread, an abrasion occurs.The tensile strength is too low.Due to this, the knot is breaking very easily.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Mfg site eval: samples received: 9 unopened and 1 open racepack.There are no previous complaints of this code/batch.There are no units in oem stock.Test the knot pull tensile strength of the samples received and the results fulfil the requirements of the oem.Review the batch mfg record, this product had a normal process and the results during the process fulfil oem requirements.Final conclusion: the complaint is corresponding (not justified).Actions on product: not applicable.Corrective/ preventive actions: not applicable.

• Brand Name: PREMILENE 4/0 (1.5) 45CM DS19 (M)
• Type of Device: NON-ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3850444
• MDR Text Key: 4614949
• Report Number: 2916714-2014-00172
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: C2090220
• Device Catalogue Number: C2090220
• Device Lot Number: 113473
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other