MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 5/0 (1) 45CM DS19 (M); SUTURES

Model Number C0933198

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation on-going.Device not returned.

Event Description

(b)(6).It is reported that the thread cracks easily near the needle.

Manufacturer Narrative

Samples received: 1 open pouch.Analysis and results: there are no previous complaints of this code batch.Manufactured (b)(4) units of this code batch.There are (b)(4) units in stock.Received one open and used sample with the thread broken near the needle attachment (approximately 1 cm to the needle attachment).Without any closed samples an analysis can not be performed in order to make a decision.Twelve units of stock for analysis was requested.Tested the knot pull tensile strength of the samples of stock and the results fulfill the oem requirements.Tested the needle attachment of the samples of stock and the results fulfill the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Remarks: "when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material".Final conclusion: although the results of the samples of stock fulfill the oem specifications, note of this incident is 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.

• Brand Name: DAFILON BLUE 5/0 (1) 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: 6139945
• MDR Text Key: 61310152
• Report Number: 2916714-2016-00990
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151165
• 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,Followup
• Report Date: 02/01/2017

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: 04/01/2021
• Device Model Number: C0933198
• Device Catalogue Number: C0933198
• Device Lot Number: 616136V004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2016
• Date Manufacturer Received: 01/23/2017
• 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