MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 0 (3.5) 90CM HR37S (M); SUTURE

Model Number C0068956

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Packaging Problem (3007); Inaccurate Information (4051)

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

Event Date 07/25/2018

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Wrong product inside box.

Manufacturer Narrative

Samples received: none but pictures received.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.Regarding to the product found inside the box (b)(4), we manufactured and mostly distributed (b)(4) units into the market.There are 24 units in stock in b.Braun surgical's warehouse.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.Reviewed the batch manufacturing record of the product found inside the box, there is an internal non conformity related to a labeling issue.Both products were packed very close in time in the manufacturing area.We assume that the clean line was not correctly performed and some units of the previous order (c1049619, batch 118113) were packed with the product c0068956 and batch 118114.Final conclusion: taking into account that the results of the analysis show that the product did not fulfil the specifications of the european pharmacopoeia/b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the pictures received.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: NOVOSYN VIOLET 0 (3.5) 90CM HR37S (M)
• Type of Device: SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7814203
• MDR Text Key: 118229261
• Report Number: 3003639970-2018-00511
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068956
• Device Catalogue Number: C0068956
• Device Lot Number: 118114
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2018
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other