MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M); SUTURES

Model Number C0068047

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.

Event Description

Country of complaint: (b)(6).The hospital stated that when they opened one novosyn 0068047, there was 2 sutures with 2 needles while it should be only one.

Manufacturer Narrative

Samples received: 2 unopened pouches and 1 opened.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 two closed samples and one open and unused sample with two sutures outside from the pack.We have checked the open sample received and there are two visible marks of needles inside the first pack as can be seen in enclosed picture.This defect could have been caused by the automatic winding machine during the manufacturing process.The machine took two sutures instead of one in the winding step.On the other hand, we have checked the two closed samples received and both are correct.These closed samples have one suture inside.Taking into account that no other complaints have been received concerning this issue for this code batch, and the closed samples have only one suture inside, we consider that this is an isolated unit, but the rest of units of the affected batch are correct.Final conclusion: taking into account that the results of the open sample received does not fulfil product specifications, we conclude that the complaint is justified.Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.

• Brand Name: NOVOSYN VIOLET 2/0 (3) 70CM HR30 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7267072
• MDR Text Key: 99930126
• Report Number: 3003639970-2018-00074
• 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: 02/20/2018

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: 12/19/2021
• Device Model Number: C0068047
• Device Catalogue Number: C0068047
• Device Lot Number: 116511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Distributor Facility Aware Date: 02/01/2018
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other