MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 3/0 (2) 10X60CM; SUTURES

Model Number C0058182

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).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaints: (b)(6).It was reported that wrong product was inside the box.

Manufacturer Narrative

Samples received: none, pictures.Analysis and results: there are no previous complaints of this reference-batch.We manufactured (b)(4) units of this code-batch and distributed to gulf medical co.Ltd.There are no units in our stock.We have only received a picture of the front label of the box that corresponds to the code-batch c0058182-117286 (novosyn violet 3/0(2) 10x60cm) and a picture of the product inside the box that corresponds to the code-batch c0068766-117174 (novosyn violet 3/0 (2) 70cm hr20 (m)).According to the information received, the 36 units correspond to the code-batch c0068766-117174.Products traceability has been checked and this mix-up probably took place at the moment of preparing the shipment in the warehouse, a box that contained (b)(4) units of the code-batch c0068766-117174 was labelled with the code-batch c0058182-117286 by mistake and was shipped to gulf medical co.Ltd.However, without samples or back label of the box a proper analysis cannot be performed.Taking into account the pictures received, we conclude that the complaint is confirmed.Nevertheless, if we receive the back label of the box or the involved box, we will re-open the case to investigate it.Final conclusion: 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 3/0 (2) 10X60CM
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7591496
• MDR Text Key: 110851515
• Report Number: 3003639970-2018-00343
• 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: 10/31/2018

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 Model Number: C0058182
• Device Catalogue Number: C0058182
• Device Lot Number: 117286
• Distributor Facility Aware Date: 05/17/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 10/17/2018
• Supplement Dates FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other