MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. PREMILENE 2/0 (3) 75CM HR26S CV

Model Number C2095442

Device Problems Break (1069); Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Needle thread connection weak.Breaks off during routine procedure.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: samples received: 22 unopened and 3 open racepacks.Reviewed the batch manufacturing record, this product had a normal process and the results during the process.Needle attachment results conducted on samples before releasing the product fulfilled oem requirements.There are previous complaints of this code/batch.There are no units in oem stock.The needle attachment of closed samples received was tested and the results fulfill the requirements of the oem.Final conclusion: the complaint is corresponding (justified).Corrective/preventive actions: oem has opened a corrective action in order to avoid this kind of incidents in the future.

• Brand Name: PREMILENE 2/0 (3) 75CM HR26S 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) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr.; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3818899
• MDR Text Key: 4402264
• Report Number: 2916714-2014-00066
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: K980703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: C2095442
• Device Catalogue Number: C2095442
• Device Lot Number: 112133
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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