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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOSYN UNDYED 4/0 (1.5) 70CM DS12 (M); SYNTHETIC ABSORBABLE SUTURE

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B. BRAUN SURGICAL S.A. MONOSYN UNDYED 4/0 (1.5) 70CM DS12 (M); SYNTHETIC ABSORBABLE SUTURE Back to Search Results
Model Number C0023414
Device Problems Battery charger, defective (1054); Detachment Of Device Component (1104)
Patient Problem Not Applicable (3189)
Event Date 04/23/2014
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Thread detached from needle.
 
Manufacturer Narrative
Manufacturing site evaluation: samples received: 1 open pouch.There are no previous complaints of this code/batch.There are no units in oem stock.We have received 1 open sample with the needle detached from the thread.Thread is still wound on the pack.Without any closed sample we cannot carry out a complete analysis.Needle attachment results conducted on samples before releasing the product fulfilled the requirements of the oem.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils oem requirements.Remarks: the complaint is justified for isolated detached needle, but the conclusion is not corresponding according to the results of the in process control when this batch was manufactured.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive actions: not applicable.Us reporting agent notified on (b)(6)2014.
 
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Brand Name
MONOSYN UNDYED 4/0 (1.5) 70CM DS12 (M)
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 SA
121 carretera de terrassa
rubi (barcelona) 0819 1
SP   08191
Manufacturer Contact
michelle link
615 lambert pointe drive
hazelwood, MO 63042
3145515938
MDR Report Key3880707
MDR Text Key4462515
Report Number2916714-2014-00404
Device Sequence Number1
Product Code GAM
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K011375
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 05/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2018
Device Model NumberC0023414
Device Catalogue NumberC0023414
Device Lot Number113143V004
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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