MAUDE Adverse Event Report: B. BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 45CM DS19; SUTURES

Model Number C0932205

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: date of event: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "the needle was too easily detached from the thread with hands." (even with light forces with bare hands, before it was gripped by needle holder, the suture was ruptured).

Manufacturer Narrative

Manufacturing site evaluation: no samples received.After almost 3 months without response if samples will be available we will analyze the case without samples, if samples are received in the future we will re-open the case.Analysis and results - there are no previous complaints of this code batch.There are no units in our stock.Without closed samples and/or defective samples a proper analysis cannot be performed.Final conclusion - a proper analysis and testing could not be done and the case is not confirmed due to lack of evidence.Nevertheless, the complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: DAFILON BLUE 4/0 (1.5) 45CM DS19
• Type of Device: SUTURES
• Manufacturer (Section D): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7878269
• MDR Text Key: 120395513
• Report Number: 3003639970-2018-00579
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K151165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932205
• Device Catalogue Number: C0932205
• Device Lot Number: 617314
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/24/2018
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1