MAUDE Adverse Event Report: B BRAUN SURGICAL SA BONE WAX 24X2.5G

Model Number 1029754

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Blood Loss (2597)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint sample was returned for evaluation, a supplemental report will be forwarded at the completion of the investigation.

Event Description

It was reported that the reported by an anonymous end user, that the bone wax is not sticky and made it not possible to stop the bleeding.

Manufacturer Narrative

User complained that bone wax is not sticky, it is not easy to stop bleeding.The information of user is undisclosed, so there's no possibility to get further information of the case.No patient information available.End customer is anonymous.No samples was received.There is a previous complaint of this code batch regarding the same issue, closed as not confirmed after the analysis of the samples received.We manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical's warehouse.We have not received samples, nevertheless the previous complaint for the same code batch received 2 samples.The samples received in the previous complaint fulfilled the visual specifications of the product.The samples received were also tested for handling use.This means that the application was simulated and no abnormalities were found.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Prefabrication documentation was also reviewed and no deviations were found, individual raw materials (beeswax and vaseline) were checked and the product fulfill the specifications of the european pharmacopoeia.In conclusion the results of the samples received fulfil the specifications of european pharmacopoeia/b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Based on the conclusion derived from investigation, it is not required to make actions in distributed product.A capa has been initiated to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: BONE WAX
• Manufacturer (Section D): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7873496
• MDR Text Key: 120156792
• Report Number: 3003639970-2018-00571
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 218082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Distributor Facility Aware Date: 09/03/2018
• Date Manufacturer Received: 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other