MAUDE Adverse Event Report: B. BRAUN SURGICAL SA MONOSYN VIOLET 3/0 (2) 70CM HR17 (M); SYNTHETIC ABSORBABLE MONOFILAR

Model Number C0022005

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Component Misassembled (4004)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "that prior to use it was noticed that instead of one needle and suture in the package, the package contained an additional suture and needle." no patient information as occured before use.

• Brand Name: MONOSYN VIOLET 3/0 (2) 70CM HR17 (M)
• Type of Device: SYNTHETIC ABSORBABLE MONOFILAR
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8070724
• MDR Text Key: 128400764
• Report Number: 3003639970-2018-00700
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0022005
• Device Catalogue Number: C0022005
• Device Lot Number: 118097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/16/2018
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: No
• 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