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

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.

• Brand Name: CONTIPLEX®
• Type of Device: ANESTHESIA 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 Key: 6420558
• MDR Text Key: 70436033
• Report Number: 2523676-2017-00033
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K090995
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 331693
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• 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 Sequence Number: 1
• Treatment: (B)(4); (B)(4); (B)(4); (B)(4); (B)(4)
• Patient Outcome(s): Hospitalization; Disability