MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 75CM DS19 (M); OTHER SUTURE

Model Number C0933252

Device Problem Detachment of Device or Device Component (2907)

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

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: 1 unopened pouch.Analysis and results: there are no previous complaints of this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have received one closed sample for analysis.We have tested the needle attachment strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): 1.40 kgf (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).We have also tested the knot pull tensile strength of the sample received and the result fulfils the requirements of the european pharmacopoeia (ep): 1.56 kgf (ep requirements: 0.92 kgf in average and 0.31 kgf in minimum).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: when working with dafilon 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 sample 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.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 there was needle detachment.The reporter indicated that there is an issue with the suture, the needle detaches from the thread and also the thread breaks.Requests for patient information and additional event details have been unsuccessful.

• Brand Name: DAFILON BLUE 3/0 (2) 75CM DS19 (M)
• 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: 9712211
• MDR Text Key: 179730640
• Report Number: 3003639970-2020-00102
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: MO
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: C0933252
• Device Catalogue Number: C0933252
• Device Lot Number: 619135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/14/2020
• 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