MAUDE Adverse Event Report: B.BRAUN SURGICAL SA BONE WAX 24X2.5G; HAEMOSTYPTICS, PROPHYLAXIS OF

Model Number 1029754

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K000021.If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there is no label on the bone wax.The reporter indicated the label is missing on the packaging.The event occurred prior to use.

Manufacturer Narrative

Investigation: samples received: 1 unopened pouch.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4).There are no units in bbs stock.We have received a closed pouch without printed label in it.This defect was caused in the production area.As no other complaints have been received of this code batch we consider that this unit is an isolated and accidental defect that was not detected at the moment of packaging the product.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.Final conclusion: taking into account that the sample received does not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the sample received.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: HAEMOSTYPTICS, PROPHYLAXIS OF
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9258393
• MDR Text Key: 172459899
• Report Number: 3003639970-2019-00742
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 12/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 218482
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1