MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 6/0 (0,7) 45CM DS12 POW; SUTURES

Model Number C0938060

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: samples received: 6 samples of dafilon 6/0 in original closed packaging are attached.Preliminary analysis: stock review: of the lot and reference reported in the claim, there are no units in stock.Quantity produced / imported: reviewed the traceability and verify that of this lot and product code, a total of (b)(4) units were manufactured.Distributed quantity: the entire lot was distributed to 4 customers in cities such as: (b)(6).Background: reviewed the database of claims from the manufacture of the batch in 2015 and verify that no claims related to this product and cause code have been received to date.Batch record / batch record: the documentation for the batch manufacturing was reviewed and no deviations or changes during the process are recorded.Results for batch release: array resistance analyzes (bonding needle-thread) for batch release met the requirements of the oem requirements.Analysis of the sample (s): the samples received were visually inspected and were in their original, closed packaging.The samples received were subjected to a test of resistance to reinforcement (needle-wire bonding), the samples complied with the oem requirements.Conclusions: based on the analysis performed, the claim is identified as "not justified".We appreciate your cooperation and regret any inconvenience this problem may have caused.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

Country of complaint: (b)(6).It was reported that the needle detached from the thread.

• Brand Name: DAFILON BLUE 6/0 (0,7) 45CM DS12 POW
• 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: 6422021
• MDR Text Key: 70550767
• Report Number: 3003639970-2017-00140
• Device Sequence Number: 1
• Product Code: GAR
• 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
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0938060
• Device Catalogue Number: C0938060
• Device Lot Number: 515464
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/06/2017
• Date Manufacturer Received: 02/23/2017
• 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