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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 2/0 (3) 75CM DS24 SUTURES

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B.BRAUN SURGICAL SA DAFILON BLUE 2/0 (3) 75CM DS24 SUTURES Back to Search Results
Model Number C0935360
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Pain (1994)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: samples received: 1 unopened pouch. Analysis and results: there are no previous complaints of this code-batch. Manufactured and distributed in the market (b)(4) units of this code-batch. There are no units in stock. Thread surface on the closed sample received is the current and the usual one, no defects have been found. On the other hand, sewing test on artificial skin tissue has been conducted with the sample received and the thread slips correctly through the tissue. Moreover, the stitches have been removed from the tissue without difficulty. Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements. Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken 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.

 
Event Description

Country of complaint: (b)(6). It was reported that after sutures, thyroid - the day after a surgery; hernia - 7th day after a surgery. In one case, the suture was removed - it was very painful for a patient. All med watch submissions related to this report are: 3003639970-2018-00173, 3003639970-2018-00204, 3003639970-2018-00205.

 
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Brand NameDAFILON BLUE 2/0 (3) 75CM DS24
Type of DeviceSUTURES
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7430988
MDR Text Key105931186
Report Number3003639970-2018-00204
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodePL
PMA/PMN NumberK990090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC0935360
Device Catalogue NumberC0935360
Device LOT Number617151
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date04/05/2018
Event Location No Information
Date Manufacturer Received02/27/2018
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 TREATMENT DATA
Date Received: 04/13/2018 Patient Sequence Number: 1
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