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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX® ANESTHESIA CONDUCTION KIT

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B. BRAUN MEDICAL INC. CONTIPLEX® ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 331693
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 10/11/2016
Event Type  Injury  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. (b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn. The investigation into this reported event is ongoing. A follow-up report will be submitted when the results of the investigation are available. Note: this case is being filed based on a notification from the fda's medwatch program, report mw5067007. The initial reporter information on this report is unknown, so further attempts to get a sample and more information were not possible. The initial reporter filed their report against seven items and batches, however the other items listed in concomitant medical products are not b. Braun manufactured products.
 
Event Description
As reported by user facility: postop from elective right total knee replacement, patient developed increased pain, swelling and redness to right thigh. Patient returned to operating room on post op day 4, for necrotizing fasciitis of the right thigh musculature and fascial planes anteriorly and removal of hardware.
 
Manufacturer Narrative
(b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. If additional pertinent information becomes available a follow-up report will be filed.
 
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Brand NameCONTIPLEX®
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
6102660500
MDR Report Key6420558
MDR Text Key70436033
Report Number2523676-2017-00033
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K090995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 02/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number331693
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/21/2017 Patient Sequence Number: 1
Treatment
(B)(4); (B)(4); (B)(4); (B)(4); (B)(4)
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