MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 1(4)4X45CM HR48TO(M); SUTURES

Model Number B0088787

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4) is submitting this report on behalf of b.Braun surgical s.A.(manufacturer).Exemption number: (b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Three units of the reference (b)(4) inside the box of the reference (b)(4).

Manufacturer Narrative

Samples received: the box of product and 3 unopened pouches.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market 1,248 units of this code-batch.There are no units in our stock.We have received one box of product of the code-batch b0088787-118055 (novosyn violet 1(4)4x45cm hr48to) that contains three unopened pouches of the code-batch g0058715-118072 (novosyn violet 3/0 (2) 250cm aro).Both products were packed one after the other by the same operator.We assume that clean line in the manufacturing process was not performed correctly and three units of the code-batch g0058715-118072) were packed in a box of the code-batch b0088787-118055.As no other complaints have been received concerning this issue, we consider that this is an isolated and accidental box.All stock of the code-batch g0058715-118072 has also been checked and the result has been conform.Final conclusion: taking into account that the samples received do not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: NOVOSYN VIOLET 1(4)4X45CM HR48TO(M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7504253
• MDR Text Key: 108363147
• Report Number: 3003639970-2018-00314
• 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: 06/19/2018

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: 02/02/2023
• Device Model Number: B0088787
• Device Catalogue Number: B0088787
• Device Lot Number: 118055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2018
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other