MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL VIOLET 0 (3.5) 70CM DS30 (M); SUTURES

Model Number G1048248

Device Problems Failure To Adhere Or Bond (1031); Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 11/26/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaints: (b)(6)."on the box ref.(b)(4) - safil o ds30 it was found six units from ref.(b)(4) safil 0 (without needle).One of the six sachets was opened during the surgery.It is requested the replacement of 6 units of ref.(b)(4) safil o ds30.".

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).Item box indicated item 1048248 (safil o ds30); however, inside the box was item 1038208 (safil 0) without needle.One package of incorrect item number was opened during surgery.

• Brand Name: SAFIL VIOLET 0 (3.5) 70CM DS30 (M)
• 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: 5347667
• MDR Text Key: 35262130
• Report Number: 2916714-2015-01148
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K031286
• 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,Followup
• Report Date: 12/18/2015

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 Model Number: G1048248
• Device Catalogue Number: G1048248
• Device Lot Number: 113063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/18/2015
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other