• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 75CM DS24; OTHER SUTURE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B.BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 75CM DS24; OTHER SUTURE Back to Search Results
Model Number G0935344
Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
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.K1227340.If additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported needle detachment.The reporter indicated that the needle detaches from the thread (it breaks from the junction needle and the suture).Additional information has been requested.
 
Manufacturer Narrative
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): 0.93 kgf (ep requirements: 0.46 kgf in average and 0.23 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): 1.24 kgf (ep requirements: 0.51 kgf in average and 0.15 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.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DAFILON BLUE 4/0 (1.5) 75CM DS24
Type of Device
OTHER SUTURE
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP  08191
MDR Report Key9643409
MDR Text Key176984410
Report Number3003639970-2020-00024
Device Sequence Number1
Product Code GAR
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG0935344
Device Catalogue NumberG0935344
Device Lot Number619144
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/09/2020
Initial Date FDA Received01/29/2020
Supplement Dates Manufacturer Received02/11/2020
Supplement Dates FDA Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-