MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 90CM DS19; SUTURES

Model Number C0935239

Device Problems Break (1069); Material Frayed (1262); Knotted (1340)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: samples received: 30 unopened pouches.Analysis and results: there are no previous complaints of this code batch.(b)(4) units were manufactured and distributed.There are no units in stock.Received 30 closed samples.Tested the knot pull tensile strength of the samples received and the results fulfills the oem requirements.As indicated in the dafilon instructions for use: "when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked." checked the thread surface of the closed samples received and the visual appearance is the correct and the usual one.Thread has been also analyzed according to flexibility test and values are the usual ones.Results are in the current range for this thread and size.The knot security control has been conducted with the samples received and results are into the current range for this thread and size as well.Final conclusion: complaint is not justified.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to take an actions in the product.Customer will receive a credit note for one box of product as a quality courtesy.Corrective/preventive actions: according to the 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).The thread breaks extremely easily, forming at the break a fraying of the thread and the thread slides on the first knot, making it difficult for the second knot.Also, the wire is very elastic and the shape memory is excessively marked.The thread is damaged.

• Brand Name: DAFILON BLUE 3/0 (2) 90CM DS19
• 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: 5183531
• MDR Text Key: 29610884
• Report Number: 2916714-2015-00921
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: C0935239
• Device Catalogue Number: C0935239
• Device Lot Number: 615182V006
• Date Manufacturer Received: 09/29/2015
• 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