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

Model Number 1029754

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the bone wax.During surgery, the surgeon complained that the bone wax was not sticky.It affected application and he could not smear it directly onto the bone to stop bleeding; instead, he needed to press on the bone with a finger.Patient outcome was not provided but no harm or intervention was noted.No patient information is available.

Manufacturer Narrative

Samples received: 1 small piece of bone wax (approx.1 cm2).Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received one open sample, only one small piece of bone wax (approx.1cm2).However, without any closed sample or more quantity of bone wax sample, we cannot carry out a proper analysis in order to take a decision.Anyway, we have checked this open sample received and the aspect is the usual and correct one.The sample received fulfills the visual specifications of the product, no abnormalities have been found.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according 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: HAEMOSTYPTICS
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8275397
• MDR Text Key: 134087784
• Report Number: 3003639970-2019-00064
• 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: 02/28/2019

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: 218073
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/26/2019
• Initial Date Manufacturer Received: 12/25/2018
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 02/26/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1