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

Model Number C0933201

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 4 unopened pouches.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.Tested the needle attachment of the samples received and the results fulfill the oem requirements.A minimum of five samples would be preferred because is the minimum number of units that requires the oem requirement.Final conclusion: although the results of the samples received fulfill the oem specifications, note is taken of this incident 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).It was reported that the needle detached from the thread easily.

• Brand Name: DAFILON BLUE 4/0 (1.5) 45CM DS19 (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: 6139928
• MDR Text Key: 61308898
• Report Number: 2916714-2016-00998
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K990090
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2021
• Device Model Number: C0933201
• Device Catalogue Number: C0933201
• Device Lot Number: 616291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Distributor Facility Aware Date: 11/17/2016
• Date Manufacturer Received: 11/03/2016
• 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