MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SUPRAMID BLACK 3/0 (2) 75CM DS24; SUTURES

Model Number C0714356

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 21 unopened pouches and 2 opened.Analysis and results: there are no previous complaints of this code-batch.Manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.Thread surface in closed samples received after pulling out the threads from the packs is correct and the usual one.No defects have been found.Furthermore, sewing test on artificial skin tissue has been conducted with the sample received and fraying does not appear when pulling the thread through the tissue.Visual appearance is the usual one as can be seen on enclosed picture, before and after sewing test.Tested the needle attachment of the closed samples received and the results fulfill the oem requirements.1.21 kgf in average and 0.84 kgf in minimum (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).Final conclusion: although the results of the closed samples received fulfill the oem specifications, note of this incident was taken in order to assess if new or additional actions are needed.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.

Event Description

Country of complaint: (b)(6).After passing through, it was noted that the suture has defects.Second thread has also exhibited this detachment.

• Brand Name: SUPRAMID BLACK 3/0 (2) 75CM DS24
• 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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7511340
• MDR Text Key: 108564043
• Report Number: 3003639970-2018-00265
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: C0714356
• Device Catalogue Number: C0714356
• Device Lot Number: 617032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Distributor Facility Aware Date: 04/30/2018
• Date Manufacturer Received: 04/16/2018
• 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