MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOPLUS VIOLET 4/0 (1.5) 70CM DR18 (M); SUTURES

Model Number C0024448

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 72 unopened pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured (b)(4) units of this code batch, there are no units in stock.Tightness test to the samples received has been performed and the units are tight.Tested the knot pull tensile strength of the samples received and the results fulfill the requirements of the oem.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: as indicated in the instructions for use of the product: "when working with monoplus® suture material, great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders do not cause any crushing or crimping damage to the suture material.Final conclusion: although the results of the closed samples received fulfill the specifications of oem requirements, note is taken of this incidence in order to assess if new or additional actions are needed.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to take actions in distributed product.The customer will receive a credit note for two boxes of product for the units sent.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).Suture snaps when held by needleholder.

• Brand Name: MONOPLUS VIOLET 4/0 (1.5) 70CM DR18 (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: 5644641
• MDR Text Key: 44893198
• Report Number: 2916714-2016-00369
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: K031216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2020
• Device Model Number: C0024448
• Device Catalogue Number: C0024448
• Device Lot Number: 115483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2016
• Distributor Facility Aware Date: 05/06/2016
• Date Manufacturer Received: 04/14/2016
• 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