MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. PREMILENE 3/0 (2) 75CM HR17 (M) CV

Model Number C2090014

Device Problems Device Difficult to Setup or Prepare (1487); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint states: several threads have torn during surgery without a high pulling force.Furthermore, there have been some products where the needle and the thread were not connected, they lay loose inside the race packs.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Manufacturing site evaluation: samples received: 1 opened racepack.There are no previous complaints of this code/batch.There are no units in oem stock.We have received one open sample with the needle detached from the thread.Thread is still wound on the pack.We have tested the knot pull tensile strength of the sample received and the result fulfill the requirements of the oem.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill oem requirements.Regarding the defect of the needle and the thread were not connected, without any closed sample we cannot carry out an analysis in order to take a decision.Final conclusion: the complaint is not corresponding (not justified).

• Brand Name: PREMILENE 3/0 (2) 75CM HR17 (M) CV
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi (barcelona) ; SP
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4047679
• MDR Text Key: 20012603
• Report Number: 2916714-2014-00634
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K980703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: C2090014
• Device Catalogue Number: C2090014
• Device Lot Number: 113203V004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: No
• 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