MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOSYN VIOLET 4/0 (1.5) 70CM DS19 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C0022204

Device Problems Degraded (1153); Naturally Worn (2988)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Complaint: needle blunt.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2015.Manufacturing site evaluation: evaluaiton is ongoing.

• Brand Name: MONOSYN VIOLET 4/0 (1.5) 70CM DS19 (M)
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; ES 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; ES 08191
• Manufacturer Contact: nicole broyles ; 615 lamert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4713832
• MDR Text Key: 16988603
• Report Number: 2916714-2015-00328
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: C0022204
• Device Catalogue Number: C0022204
• Device Lot Number: 114121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2015
• 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