MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. BONE WAX 24X2.5G; BONE WAZ

Model Number 1029754

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Not Applicable (3189)

Event Date 04/07/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).We received an info from a customer concerning the labeling of bone wax, ref (b)(4) that is not in (b)(4).The batch number is (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: samples received: none.There are no previous complaints received for this code batch.There are four country-specific label layouts (b)(4) for this article number.These layouts are assigned to the storage locations in sap database.The complaint product has the layout (b)(4) and the layout that includes portuguese is (b)(4).According to the dhr the batch number complained is correctly labeled.The article number (b)(4) and the batch number (b)(4) was labeled with the layout (b)(4).The shipping mistake took place when the subsidiary in (b)(6) removed the "material determination" in sap and when they introduced the order and system choose the incorrect layout.Final conclusion: the complaint is corresponding (justified).Corrective/preventive actions: this error has been corrected.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: BONE WAZ
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi, barcelona 0819 1; ES 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 0819 1; ES 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3829717
• MDR Text Key: 4391266
• Report Number: 3005673311-2014-00048
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: K000021
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 213424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• 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
• Patient Outcome(s): Other