MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. DAFILON BLUE 5/0 (1) 45CM DSMP16 (M); NYLON SUTURE

Model Number C0936154

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Wound Dehiscence (1154)

Event Type  malfunction  

Event Description

Country of complaint: (b)(4).Needle bent, blunt and knotting is difficult.Dehiscence and extrusion points.

Manufacturer Narrative

Waiting for product return.Us reporting agent notified on: (b)(4) 2015.Evaluation is ongoing.

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DSMP16 (M)
• Type of Device: NYLON 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 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4436159
• MDR Text Key: 5316660
• Report Number: 2916714-2015-00008
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2019
• Device Model Number: C0936154
• Device Catalogue Number: C0936154
• Device Lot Number: 614195
• Date Manufacturer Received: 12/02/2014
• 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
• Patient Outcome(s): Other