MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 1 (4) 90CM HR40S (M); SUTURES

Model Number C0068557

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: samples received: none.Analysis and results: there are no previous complaints of this code batch.(b)(4) units were manufactured and distributed ,there are no units in stock.Received one picture (visual inspection) which shows that inside a novosyn pre-printed box labeled as c0068557 (novosyn violet 1 (4) 90cm hr40s) with batch 115075 there are (b)(4) pouches of the reference (b)(4) (novosyn violet 2/0 (3) 70cm hr26) with batch 115074.Note pictures are not attached to this file.Products traceability has been checked and it has been determined that this mix-up took place in the manufacturing line in the packaging area.Both products were packed in the same line and same day one after the other.Line clearance was not correctly done.Final conclusion: complaint is justified, taking into account that the box contains wrong product inside.Actions on distributed product of this reference/batch: sent a credit note for one box of product as a compensation to the customer.Final conclusion: there is an improvement project lean_01_2012 that includes the analysis of the origin of all possible mix-ups and implementation of actions.One of the actions included in these projects is automatic packaging.This would avoid that units of another reference are packed.

Event Description

Country of complaint: (b)(6).Ordered products(article no.(b)(4)) are not match with actual products(article no.(b)(4)) mix-up: wrong product inside the box.

• Brand Name: NOVOSYN VIOLET 1 (4) 90CM HR40S (M)
• 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: 5185097
• MDR Text Key: 29742164
• Report Number: 2916714-2015-00909
• 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
• Report Date: 10/27/2015

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: 02/01/2020
• Device Model Number: C0068557
• Device Catalogue Number: C0068557
• Device Lot Number: 115075
• Initial Date Manufacturer Received: 09/21/2015
• Initial Date FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other