MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT CHROM 3.5= 2/0 90CM 1XHR 37S; SUTURES

Model Number B0565105

Device Problems Failure To Adhere Or Bond (1031); Break (1069); Material Rupture (1546)

Patient Problem Wound Dehiscence (1154)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the suture had several issues per day from needle rupture, broken thread, patient dehiscence, detachment from needle before the start of a procedure.

Manufacturer Narrative

Samples received: 1 unopened unit.Analysis and results: there are no previous complaints of this batch regarding needle breakage.We have received one closed sample for analysis.The needle of the sample received has been tested for bending strength and the result fulfills product specifications: 36.15 nxcm in minimum.Minimum bending strength specification: > 33 nxcm.Bending strength results before releasing the product were 33.44 nxcm and 35.58 in minimum and fulfilled the specifications of the product.Remarks: care should be taken to avoid damage when handling surgical needles.Grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage.Final conclusion: although the result of the sample received fulfils the product specifications, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: CATGUT CHROM 3.5= 2/0 90CM 1XHR 37S
• Type of Device: SUTURES
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6673086
• MDR Text Key: 78585495
• Report Number: 3003639970-2017-00340
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0565105
• Device Catalogue Number: B0565105
• Device Lot Number: 516471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/27/2017
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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