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

Model Number 1029754

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: date of event: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "after opening the package it was discovered it was empty.".

Manufacturer Narrative

Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in b.Braun surgical's warehouse.We have received 24 units.One is closed and empty.The primary and secondary packaging is intact.The primary pack was marked as empty during production but it was not discarded.We assume a human error of the operator that did not discard the defective unit.As there are no previous complaints, we assume that this is an isolated unit.A review of the batch manufacturing record was performed.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 results of samples received do not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.No corrective or preventative actions needed.

• 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: 7960449
• MDR Text Key: 123809815
• Report Number: 3003639970-2018-00661
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 217384
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/22/2018
• Date Manufacturer Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1