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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 4/0 (1.5) 8X45CM HR17TOMTD; SYNTHETIC ABSORBABLE SUTURE
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B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 4/0 (1.5) 8X45CM HR17TOMTD; SYNTHETIC ABSORBABLE SUTURE Back to Search Results
Model Number M0088185
Device Problem Battery charger, defective (1054)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Tip of the needle bends easily when grabbed with forcep during tissue penetration.
 
Manufacturer Narrative
Us reporting agent notified on: (b)(4) 2014.Evaluation on-going at manufacturing site.
 
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Brand Name
NOVOSYN VIOLET 4/0 (1.5) 8X45CM HR17TOMTD
Type of Device
SYNTHETIC ABSORBABLE SUTURE
Manufacturer (Section D)
B. BRAUN SURGICAL S.A.
rubi (barcelona) 0819 1
SP  08191
Manufacturer (Section G)
B. BRAUN SURGICAL S.A.
121 carreterra de terrassa
rubi (barcelona) 0819 1
SP   08191
Manufacturer Contact
michelle link
615 lambert pointe dr.
hazelwood, MO 63042
3145515938
MDR Report Key3877221
MDR Text Key4512108
Report Number2916714-2014-00366
Device Sequence Number1
Product Code GAM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K122734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 05/19/2014
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 Expiration Date01/01/2019
Device Model NumberM0088185
Device Catalogue NumberM0088185
Device Lot Number114024V004
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/09/2014
Initial Date FDA Received05/19/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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