MAUDE Adverse Event Report: B BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 75CM DS19 POW; SUTURE

Model Number C0930240

Device Problem Dull, Blunt (2407)

Patient Problem Inflammation (1932)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Starts suture without problem, but after using the first half of nylon, the needle becomes blunt which caused the tissue to tear in the remaining points, which resulted in inflammation of the tissue.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2015.Mfg site eval: eval on-going at oem.

• Brand Name: DAFILON BLUE 4/0 (1.5) 75CM DS19 POW
• Type of Device: SUTURE
• Manufacturer (Section D): B BRAUN SURGICAL SA; rubi, barcelona 0819 1; SP 08191
• Manufacturer (Section G): B BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 0819 1; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4577243
• MDR Text Key: 21175085
• Report Number: 2916714-2015-00150
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K990090
• 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: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: C0930240
• Device Catalogue Number: C0930240
• Device Lot Number: 514063
• Date Manufacturer Received: 01/22/2015
• 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