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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLACK 9/0 (0.3) 15CM DRM5; SUTURES
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B.BRAUN SURGICAL SA DAFILON BLACK 9/0 (0.3) 15CM DRM5; SUTURES Back to Search Results
Model Number G1111434
Device Problems Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6).In the complete plastic service reports that they notice dafilon 9/0 suture too rigid.Also, the knot does not hold and they used to do 1 double knot and 1 flat knot and now they have to do 1 double knot and 2 flat knots to make ensure.
 
Manufacturer Narrative
Samples received: 12 unopened units.Analysis and results: there are no previous complaints of this code-batch.We manufactured (b)(4) units of this code-batch.There are 720 units in our stock.We have received 18 closed samples to analyze this complaint.We have tested the knot security control of the samples received and the results are into the current range for this thread and size.Remarks: as indicated in the note/precautionary measures from the instruction for use of the product, dafilon® should be used applying the standard surgical suturing and knotting techniques, taking into account the surgeon's experience with the respective surgical procedure.Care should be taken that the knots are positioned properly and adequate knot security is given.On the other hand, flexibility test can not be conducted to threads of usp 9/0.The visual inspection of the threads of the closed samples received is the usual and current ones as can be seen in enclosed picture.Thread is not damaged.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the b.Braun surgical specifications, we take note of this incidence 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.
 
Manufacturer Narrative
Samples received: 12 unopened units.Analysis and results: there are no previous complaints of this code-batch.We manufactured (b)(4) units of this code-batch.There are 720 units in our stock.We have received 18 closed samples to analyze this complaint.We have tested the knot security control of the samples received and the results are into the current range for this thread and size.Remarks: as indicated in the note/precautionary measures from the instruction for use of the product, dafilon® should be used applying the standard surgical suturing and knotting techniques, taking into account the surgeon's experience with the respective surgical procedure.Care should be taken that the knots are positioned properly and adequate knot security is given.On the other hand, flexibility test can not be conducted to threads of usp 9/0.The visual inspection of the threads of the closed samples received is the usual and current ones as can be seen in enclosed picture.Thread is not damaged.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfilled b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the b.Braun surgical specifications, we take note of this incidence 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.
 
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Brand Name
DAFILON BLACK 9/0 (0.3) 15CM DRM5
Type of Device
SUTURES
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP  08191
MDR Report Key7627398
MDR Text Key112472886
Report Number3003639970-2018-00385
Device Sequence Number1
Product Code GAR
Combination Product (y/n)N
PMA/PMN Number
K990090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Model NumberG1111434
Device Catalogue NumberG1111434
Device Lot Number118045
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Distributor Facility Aware Date06/19/2018
Date Manufacturer Received05/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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