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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. STEELEX STE SET 6 (8) 4X45CM HRS48; GAQ
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B. BRAUN SURGICAL S.A. STEELEX STE SET 6 (8) 4X45CM HRS48; GAQ Back to Search Results
Model Number G0617814
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Country of complaint: (b)(6).Label (outside) and package (inside) do not match.Label of outside box shows sternum set usp 6 (g0617814;batch 113065) but inside the box there is sternum set usp 7 (g0617804, batch 112514).
 
Manufacturer Narrative
Manufacturing site evaluation: evaluation on-going, results not yet available.
 
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Brand Name
STEELEX STE SET 6 (8) 4X45CM HRS48
Type of Device
GAQ
Manufacturer (Section D)
B. BRAUN SURGICAL S.A.
rubi (barcelona) 0819 1
SP  08191
Manufacturer (Section G)
B. BRAUN SURGICAL S.A.
121 carretera de terrassa
rubi (barcelona) 0819 1
SP   08191
Manufacturer Contact
michelle link
615 lambert pointe dr.
hazelwood, MO 63042
3145515938
MDR Report Key3695106
MDR Text Key15176274
Report Number2916714-2014-00086
Device Sequence Number1
Product Code GAQ
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K023411
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/01/2018
Device Model NumberG0617814
Device Catalogue NumberG0617814
Device Lot Number113065
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/16/2014
Was Device Evaluated by Manufacturer? No
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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