MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL VIOLETT 6/0 (0.7) 45CM DS12 (M); SYNTHETIC ABSORBABLE BRAIDED

Model Number C1048206

Device Problems Dull, Blunt (2407); Detachment of Device or Device Component (2907)

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

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 suture.The needle was blunt and it was difficult to create a puncture, and the needle and the suture detached easily.Additional information has been requested.Patient data is not available.This report refers to the needle detachment.Associated medwatches: 3003639970-2019-00076.

Manufacturer Narrative

Samples received: 1 unopened pouch.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 closed sample to analyze this complaint.Tightness test to the sample received has been performed and the unit is tight.We have tested the needle attachment strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): 0.395 kgf (ep requirements: 0.17 kgf in average and 0.082 kgf in minimum).Reviewed the batch manufacturing record, there are no incidences related to this issue and the results during the process fulfil usp/ep and b.Braun surgical requirements.On the other hand, we have checked the needle of the sample received and the aspect of this needle is the current and usual one.The needle of this sample is tested for needle puncture strength and the result fulfils the specifications.The average penetration result is 0.302n.This result is lower than the specification of penetration for this needle (<0.360 n).The complained needle has better penetration performance.Reviewed the batch manufacturing record, this needle had a normal process and the results during the process fulfil the specifications.The average penetration result before releasing the product was 0.295n (punction strength specification: <0.360 n).Final conclusion: although the results of the sample 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.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: SAFIL VIOLETT 6/0 (0.7) 45CM DS12 (M)
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8306576
• MDR Text Key: 136253965
• Report Number: 3003639970-2019-00077
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K031286
• 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: 02/13/2019

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 Expiration Date: 05/09/2023
• Device Model Number: C1048206
• Device Catalogue Number: C1048206
• Device Lot Number: 118193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Distributor Facility Aware Date: 02/13/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1