MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6S; OTHER SUTURE

Model Number G1118765

Device Problem Material Integrity Problem (2978)

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

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K990090.Investigation: samples received: 53 unopened pouches.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market 360 units.There are no units in stock in b.Braun surgical's warehouse.We have received 53 closed samples.We have tested the knot pull tensile strength of the closed samples received and the results fulfill the requirements of the european pharmacopoeia (ep): 0.038 kgf in average and 0.028 kgf in minimum (ep requirement: 0.010 kgf in average).We have also tested linear pull tensile strength on the closed samples received and the results fulfill the requirements of u.S pharmacopeia (usp): 0.046 kgf in minimum and 0.053 kgf in average (usp requirement: 0.019 kgf in average).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

Event Description

It was reported that the suture broke during surgery.The reporter indicated the suture broke during a pterygium surgery.The first (broken) suture was removed and replaced.Per the reporter, the surgery time was extended greater than 15 minutes.There was no injury or harm to the patient.The patient was discharged and scheduled for follow up appointment for stitches to be removed in two months.

• Brand Name: DAFILON BLACK 10/0 (0.2) 30CM 2XDLM6S
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: silvia orus ; carretera de terrassa, 121; rubi, barcelona 08191 ; SP 08191
• MDR Report Key: 9161192
• MDR Text Key: 172004749
• Report Number: 3003639970-2019-00681
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Model Number: G1118765
• Device Catalogue Number: G1118765
• Device Lot Number: 618264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• 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 Age: 60 YR