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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 90CM DS19 SUTURES

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B.BRAUN SURGICAL SA DAFILON BLUE 3/0 (2) 90CM DS19 SUTURES Back to Search Results
Model Number C0935239
Device Problems Break (1069); Material Frayed (1262); Knotted (1340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing site evaluation: samples received: 30 unopened pouches. Analysis and results: there are no previous complaints of this code batch. (b)(4) units were manufactured and distributed. There are no units in stock. Received 30 closed samples. Tested the knot pull tensile strength of the samples received and the results fulfills the oem requirements. As indicated in the dafilon instructions for use: "when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders, does not cause the material to be damaged by being pinched or kinked. " checked the thread surface of the closed samples received and the visual appearance is the correct and the usual one. Thread has been also analyzed according to flexibility test and values are the usual ones. Results are in the current range for this thread and size. The knot security control has been conducted with the samples received and results are into the current range for this thread and size as well. Final conclusion: complaint is not justified. Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to take an actions in the product. Customer will receive a credit note for one box of product as a quality courtesy. Corrective/preventive actions: according to the 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). The thread breaks extremely easily, forming at the break a fraying of the thread and the thread slides on the first knot, making it difficult for the second knot. Also, the wire is very elastic and the shape memory is excessively marked. The thread is damaged.

 
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Brand NameDAFILON BLUE 3/0 (2) 90CM DS19
Type of DeviceSUTURES
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, barcelona 08191
SP 08191
Manufacturer (Section G)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, barcelona 08191
SP 08191
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key5183531
MDR Text Key29610884
Report Number2916714-2015-00921
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeFR
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 10/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2020
Device MODEL NumberC0935239
Device Catalogue NumberC0935239
Device LOT Number615182V006
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2015
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: 10/28/2015 Patient Sequence Number: 1
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