MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 4/0(1.5)8X45CM HR22TOMTD; SUTURES

Model Number M0088177

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Couldn't remove suture correctly.Needles are displaced in the foam.A steril withdrawal cannot be guaranteed.Packages are clean / pre-operative.

• Brand Name: NOVOSYN VIOLET 4/0(1.5)8X45CM HR22TOMTD
• 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: 5524074
• MDR Text Key: 41120190
• Report Number: 2916714-2016-00201
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/24/2016

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: 09/25/2020
• Device Model Number: M0088177
• Device Catalogue Number: M0088177
• Device Lot Number: 115395V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Distributor Facility Aware Date: 03/14/2016
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2015
• 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