MAUDE Adverse Event Report: B. BRAUN SURGICAL SA NOVOSYN VIOLET 2 (5) 70CM HR48 (M); SYNTHETIC ABSORBABLE BRAIDED

Model Number C0068063

Device Problem Dull, Blunt (2407)

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 the thread breaks easily and the needle was blunt.There was no patient harm reported.Further details about a procedure and patient were not provided.This report addresses the needle that was blunt.Associated medwatches: 3003639970-2018-00804 ; 3003639970-2018-00805 (this report).

Manufacturer Narrative

Investigation: one open sample, unused, first pack is closed was received.Analysis and results: there are no previous complaints of this code-batch of which we manufactured and distributed in the market 972 units.There are no units in stock in b.Braun surgical's warehouse.A tightness test to the sample received has been performed and the unit is tight.We have tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep):8.35 kgf (ep requirements: 6.48 kgf in average and 3.24 kgf in minimum) a minimum of five samples would be preferred because is the minimum number of units that requires the pharmacopoeia.Needle puncture strength was also performed on the needle received.The average penetration result of the sample received is 0.554 n and fulfils the punction strength specification: <0.560 n.The tip of the needle received is correct and not blunt.A review of the batch manufacturing record for this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with novosyn great care must be taken to ensure that the use of surgical instruments, such as tweezers or needle holder, does not lead to crimping damage of the suture.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.No corrective/preventive actions are needed.Associated medwatches: 3003639970-2018-00804 (this report); 3003639970-2018-00805.

• Brand Name: NOVOSYN VIOLET 2 (5) 70CM HR48 (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: 8187220
• MDR Text Key: 131497580
• Report Number: 3003639970-2018-00805
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K122734
• 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: 01/15/2019

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 Expiration Date: 11/15/2022
• Device Model Number: C0068063
• Device Catalogue Number: C0068063
• Device Lot Number: 717463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Distributor Facility Aware Date: 01/09/2019
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1