MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2 (5) 90CM HRN45 (M) DDP; SUTURES

Model Number B0068648

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).It was reported that the customer ordered product (b0068648).Inside the box was incorrect product (c0058627).

Manufacturer Narrative

Samples received: 35 unopened pouches of novosyn 0 3x45 cm (ref.(b)(4); batch 116024) in a box labeled as novosyn 2 90cm hrn45 (ref.(b)(4); batch 116023).Analysis and results: there is a previous complaint of this code batch, but regarding other issue.Manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have received one box labeled as (b)(4) batch 116023 (novosyn violet 2 90 cm hrn45) which contains 35 pouches of the code-batch (b)(4)-116024 (novosyn violet 0 (3.5) 3x45cm).Products traceability has been checked and it has been determined that this mix-up probably took place in the manufacturing line in the packaging area.Both products were packed in the same line and same day.Line clearance was not correctly done.Taking into account that no other customer complaints have been received concerning this issue for this code batch, this is considered an isolated and accidental unit, but the whole batch is correct.Final conclusion: complaint is justified.Corrective/preventive actions: there is an improvement project lean_01_2012 that includes the analysis of the origin of all possible mix-ups and implementation of actions.

• Brand Name: NOVOSYN VIOLET 2 (5) 90CM HRN45 (M) DDP
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6089824
• MDR Text Key: 59511455
• Report Number: 2916714-2016-00935
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

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: 01/31/2021
• Device Model Number: B0068648
• Device Catalogue Number: B0068648
• Device Lot Number: 116023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/04/2016
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other